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More MS news articles for January 2003

Clinical Trials In Multiple Sclerosis Winter 2003

Planned, In Progress, Recently Completed

http://www.nationalmssociety.org/pdf/research/clinicaltrials.pdf

Jan 1, 2003

This listing is prepared on behalf of the National Multiple Sclerosis Society’s Advisory Committee on Trials of New Drugs in MS from materials provided by principal investigators and from information gathered from published literature and public presentations. While we strive for accuracy and completeness, there are surely additional trials that are not included. Because clinical trials are dynamic studies, there may be inaccuracies due to changes in protocol for selected studies. For further information, please consult the listed principal investigator or the Research Programs Department of the National Multiple Sclerosis Society.

The list is arranged in alphabetical order by commercial name. Two indexes (one by generic name or product description, and one by type of MS) and a key to abbreviations are included. Where information was not provided to us or has not been reported, we have indicated that this information is “Not available.”

A current list of trials recruiting people with MS is available at http://www.nationalmssociety.org/Research-trialsrecruiting.asp

Index of Agents

Agent (Generic name or description)

3-4 diaminopyridine
4-aminopyridine (Fampridine)
Albuterol (Proventil)
Antibiotic therapy
Anesthetic cream (EMLA)
Aspirin
Azathioprine (Imuran)
Bee venom
Bone marrow/peripheral stem cell transplantation
CTLA 4-Ig (BMS 188667)
Cyclophosphamide
Dexrazoxane (Zinecard)
Dextromethorphan/quinidine (AVP-923)
Donezepil HCL (Aricept)
Estriol
Fluoxetine (Prozac)
Gabapentin (Neurontin)
Ginkgo biloba
Glatiramer acetate (Copaxone) for injection
Glatiramer acetate (Copaxone) oral
Immunoglobulin
Inosine
Insulin-like growth factor (IGF-1)
Interferon alpha (Pegolated Intron)
Interferon alpha-n3 (Alferon)
Interferon alpha-2a (Roferon)
Interferon beta 1a (Avonex)
Interferon beta-1a (ME 98 150-302005)
Interferon beta-1a (Rebif)
Interferon beta-1b (Betaseron)
Interferon tau
Interleukin-1 receptor blocker (anakinra; Kineret)
Laquinimod (ABR-215062; SAIK-MS)
Low-fat diet with fatty acids
Lymphocytapheresis
Marijuana derivatives (cannabis, tetrahydrocannabinol)
Methotrexate
Methylprednisolone
Micellar paclitaxel (PAXCEED)
Mitoxantrone (Novantrone)
Modafinil (Modiodal)
Modafinil (Provigil)
Monoclonal antibody (alemtuzumab; Campath)
Monoclonal antibody (anti-CD40 or anti-CD154; IDEC-131)
Monoclonal antibody (CNTO 1275)
Monoclonal antibody (daclizumab; Zenapax)
Monoclonal antibody (natalizumab; Antegren)
Monoclonal antibody (rituximab; Rituxan)
Monoclonal antibody (WA-J695)
Mycophenolate mofetil (CellCept)
Mycophenolic acid
Pain medication (Advil, Aleve, Tylenol)
Phosphodiesterase-4 inhibitor (Mesopram)
Phosphodiesterase-4 inhibitor (Rolipram)
Pixantrone (BBR-2778)
Prednisone
Rehabilitation
Riluzole (Rilutek)
Schwann cell transplantation
Sildenafil citrate (Viagra)
Simvastatin (Zocor)
T-cell receptor peptide (CDR2 BV6S26S5)
T-cell receptor peptide (V beta 5.25.3; ATM-027)
T-cell receptor peptide (V beta 5.26.513.1; NeuroVax)
T-cell vaccination
Teriflunomide
Testosterone (AndroGel)
Valacyclovir (Valtrex)

Index by type of MS - [I will complete the remaining index soon]

Relapsing-remitting
Secondary-progressive
Primary-progressive
Progressive-relapsing

All types
At risk
Progressive
Rapidly progressive
Transitional
With specific symptoms

Not available

Abbreviations Key

bid - twice daily
biw - twice weekly
d - day
id - intradermal
IFA - incomplete Freunds adjuvant
im - intramuscular
iv - intravenous
po - oral
PP - primary progressive
PR - progressive relapsing
qhs - at bedtime
q - every
qod - every other day
QOL - quality of life
RR - relapsing-remitting
sc - subcutaneous
SP - secondary progressive
tid - three times daily
tiw – three times weekly


Agent: 3-4 diaminopyridine
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding, placebo control
Dose/route: Dose escalation 30-60 mg/d
Outcome parameters: Fatigue Impact Scale, Visual Analogic Scale, QOL
Type of MS: All types
Number of Subjects: 60
Start date: March 2002
Observation period: 8 weeks
Investigators: G. Edan, E. Sartori
Sites: CHU de Rennes, France
Funding: French Health Ministry
Results/Publications: Not available
Last update: Spring 2002



Agent: Alferon N injection® (interferon alpha-n3) vs. Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Retrospective review of MRI scans of 40 patients treated with Alferon, 40
patients treated with Betaseron and 39 untreated patients
Dose/route: Not available
Outcome parameters: MRI, EDSS
Type of MS: Not available
Number of Subjects: 119
Start date: Not available
Observation period: Not available
Investigators: W. Sheremata and others
Sites: University of Miami
Funding: Interferon Sciences, Inc.
Results/Publications: Reduction in volume of T2-weighted lesions in both treatment groups; EDSS
down 1.07 in Alferon group, .15 in Betaseron group, and up .80 in untreated group (Interferon
Sciences, Inc. press release, November 8, 2001)
Last update: Spring 2002

Agent: AndroGel® (testosterone gel)
Mode of action/purpose of study: To affect immune function
Study description: Crossover, treatment vs. no treatment
Dose/route: 100 mg/d percutaneous vs. no treatment
Outcome parameters: MRI, blood immune studies
Type of MS: RR, Male
Number of Subjects: 24
Start date: April 2002
Observation period: 2 years
Investigators: R. Voskuhl, N. Sicotte, R. Swerdloff
Sites: University of California, Los Angeles
Funding: National MS Society
Results/Publications: Not available
Last update: Spring 2002

Agent: Antegren® (natalizumab)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, high dose vs. low dose vs. placebo
Dose/route: 3 mg/kg/mo iv, 6 mg/kg/mo iv or PBO
Outcome parameters: MRI activity, multiple clinical outcomes
Type of MS: RR, SP
Number of Subjects: 213
Start date: Fall 1999
Observation period: 6 months
Investigators: Multiple
Sites: Multicenter, International
Funding: Biogen, Inc., Elan Corporation, plc
Results/Publications: Significant reduction in Gd-MRI lesions and clinical relapses with Rx
(Abstract #S23.003, AAN 2002)
Last update: Winter 2003

Agent: Antegren® (natalizumab)
Mode of action/purpose of study: To affect immune function; also known as AFFIRM study
Study description: Double blinding, placebo control
Dose/route: Antegren 300 mg q 4 wk iv vs. PBO
Outcome parameters: EDSS, MSFC, frequency of relapse, MRI
Type of MS: RR
Number of Subjects: 900
Start date: December 2001
Observation period: 2 years
Investigators: C. Polman and others
Sites: Multicenter, International
Funding: Biogen, Inc., Elan Corporation, plc
Results/Publications: Not available
Last update: Spring 2002

Agent: Antegren® (natalizumab) and Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as SENTINEL study
Study description: Double blinding, Antegren and Avonex vs. Avonex and placebo
Dose/route: Antegren 300 mg/kg iv q 4 wk x 116 wk + Avonex vs. PBO + Avonex
Outcome parameters: Not available
Type of MS: RR
Number of Subjects: 1200
Start date: 2002
Observation period: 128 weeks
Investigators: Multiple
Sites: Multicenter, U.S. and Europe
Funding: Biogen, Inc., Elan Corporation, plc
Results/Publications: Not available
Last update: Spring 2002

Agent: Antibiotic therapy (trimethoprim and vitamin C)
Mode of action/purpose of study: To prevent urinary tract and bladder infections, and thus to reduce
MS relapses
Study description: Double blinding, placebo control
Dose/route: trimethoprim 100 mg qhs + vitamin C 500 mg bid vs. PBO + routine bladder care
Outcome parameters: Relapses
Type of MS: RR, SP, Female
Number of Subjects: 100
Start date: 2000-2001
Observation period: 24 months
Investigators: A. Cross, D. Derrington
Sites: Washington University, St. Louis
Funding: National MS Society
Results/Publications: Not available
Last update: Spring 2001

Agent: Antibiotic therapy (azithromycin and rifampin)
Mode of action/purpose of study: To control C. pneumoniae bacterial infection and affect immune
function
Study description: Double blinding, placebo control
Dose/route: Azithromycin, 500 mg qod po + Rifampin 300 mg bid po vs. PBO
Outcome parameters: EDSS, CSF, MRI
Type of MS: RR
Number of Subjects: 100
Start date: Fall 2000
Observation period: 15 months
Investigators: S. Sriram
Sites: Vanderbilt Stallworth Rehabilitation Hospital, Nashville
Funding: National MS Society
Results/Publications: Not available
Last update: Spring 2002

Agent: Antibiotic therapy (minocycline)
Mode of action/purpose of study: To affect immune function
Study description: Open label, crossover
Dose/route: 100 mg bid po
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 12
Start date: October 2001
Observation period: 36 months
Investigators: L. Metz
Sites: University of Calgary, Alberta
Funding: Canadian Institute of Health Research
Results/Publications: Not available
Last update: Spring 2002

Agent: Aricept® (donezepil HCL)
Mode of action/purpose of study: To improve verbal memory
Study description: Double blinding, placebo control
Dose/route: po
Outcome parameters: Neuropsychological test battery
Type of MS: All types
Number of Subjects: 240
Start date: February 2000
Observation period: 4 months
Investigators: S. Schwid and others
Sites: University of Rochester, NY, and others
Funding: Pfizer Inc., Esai
Results/Publications: Study terminated prematurely; results not available
Last update: Spring 2002

Agent: Aricept® (donezepil HCL)
Mode of action/purpose of study: To improve verbal memory
Study description: Double blinding, placebo control
Dose/route: 5 mg qhs for 4 wk, increased to 10 mg qhs for 20 wk
Outcome parameters: Selective Reminding Test (SRT)
Type of MS: RR, SP, PP
Number of Subjects: 65
Start date: October 1999
Observation period: 24 weeks
Investigators: L. Krupp
Sites: State University of New York, Stony Brook
Funding: NICHD, NIDRR/NIH
Results/Publications: Not available
Last update: Spring 2002

Agent: Aspirin
Mode of action/purpose of study: To improve fatigue
Study description: Double blinding, placebo control
Dose/route: 650-1900 mg/d
Outcome parameters: Fatigue Impact Scale, Fatigue Severity Scale, MS-Specific Fatigue Scale,
McNemar and paired t-tests
Type of MS: With significant MS-related fatigue
Number of Subjects: 30
Start date: Not available
Observation period: 14 weeks
Investigators: D. Wingerchuk and others
Sites: Mayo Clinic and Mayo Foundation, Rochester, MN and Scottsdale, AZ
Funding: Mayo Clinic and Foundation
Results/Publications: 42% of 26 pts who completed study reported good or excellent improvement
in fatigue levels during ASA treatment compared with 11% in placebo phase; trends towards benefit
on all scales (Abstract #S62.003, AAN 2002)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, low dose vs. high dose vs. placebo
Dose/route: 30 mcg/wk im vs. 60 mcg/wk im vs. PBO
Outcome parameters: MRI (brain and spinal cord) and clinical
Type of MS: PP
Number of Subjects: 50
Start date: November 1996
Observation period: 2 years
Investigators: A. Thompson, D. Miller
Sites: Institute of Neurology, Queen Square, London
Funding: Biogen, Inc.
Results/Publications: Decreased T2 lesion volume with Rx; no effect on any other parameter
(Abstract #O27, ECTRIMS 2000)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: q d po
Outcome parameters: MRI
Type of MS: Not available
Number of Subjects: Not available
Start date: Fall 2000
Observation period: 6 months
Investigators: T. Vollmer
Sites: Yale University, New Haven, CT; State University of New York, Buffalo
Funding: Not available
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) (albumin-free, preformulated)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 5 ml im
Outcome parameters: Safety, antigenicity
Type of MS: RR
Number of Subjects: 150
Start date: January 2000
Observation period: 2 years
Investigators: Multiple
Sites: Multiple sites
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2001

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, low dose vs. high dose
Dose/route: 30 mcg/wk vs. 60 mcg/wk
Outcome parameters: Disability, MRI
Type of MS: RR
Number of Subjects: 802
Start date: April 1996
Observation period: 3 years
Investigators: M. Clanet, L. Kappos and others
Sites: Multicenter, Europe
Funding: Biogen, Inc.
Results/Publications: Doses equally effective in all parameters over 4 years; MRI findings
corroborate clinical results (Abstracts #P03.069, P06.085, AAN 2002, Neurology 2002;59:1507-1517)
Last update: Winter 2003

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 30 mcg/wk im
Outcome parameters: Long-term safety; antibody production
Type of MS: RR
Number of Subjects: 382
Start date: 1995
Observation period: 6 years
Investigators: R. Rudick, M. Mass, M. Coates, J. Richert
Sites: State University of New York, Buffalo; Cleveland Clinic Foundation; Oregon Health &
Science University, Portland; Walter Reed Army Medical Center, Washington, D.C.; Georgetown
University, Washington, D.C.
Funding: Biogen, Inc.
Results/Publications: Not available (Neurology 1998;50:1266, Annals of Neurology 1997;50:468)
Last update: Spring 2001

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To improve attention and concentration deficits
Study description: Open label
Dose/route: 30 mcg/wk im for 12 mo
Outcome parameters: Scoring technique
Type of MS: RR
Number of Subjects: 15
Start date: December 2001
Observation period: 12 months
Investigators: J. Peters
Sites: Neuroscience Consultants, PLC, Reston, VA
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: Analysis of neuropsychological assessment to evaluate cognitive
dysfunction, and of effects of Avonex on cognitive symptoms
Study description: Physician blinding
Dose/route: Avonex 30 mcg/wk im
Outcome parameters: Neuropsychological assessment scores
Type of MS: RR
Number of Subjects: 120
Start date: August 2000
Observation period: 2 years
Investigators: J. Wilken, M. Walin, C. Sullivan, J. Usiskin, R. Kane, H. Crayton, M. Quig, J.
Simsarian, C. Sunders, R. Mandler, D. Kerr
Sites: VA Medical Center, Washington, D.C.; Georgetown University, Washington, D.C.; Johns
Hopkins Medical Center, Baltimore; VA Medical Center, Baltimore; Neurology Center of Fairfax,
Virginia; George Washington University, Washington, D.C.; University of Virginia, Charlottesville
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as CHAMPIONS study
Study description: Open label, ongoing neurological surveillance study
Dose/route: 30 mcg/wk im
Outcome parameters: Development of clinically definite MS; subsequent course
Type of MS: Individuals enrolled in CHAMPS (RR, at risk for MS) No. of Subjects: 300
Start date: November 2000
Observation period: 5-7 yrs
Investigators: R. Kinkel and others
Sites: Cleveland Clinic Foundation and others in U.S. and Canada
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2001

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as IMPACT study
Study description: Double blinding, placebo control
Dose/route: 60 mcg/wk im
Outcome parameters: Progression of disability (based on MSFC), EDSS, MRI, QOL, relapse rate
Type of MS: SP
Number of Subjects: 436
Start date: March 1998
Observation period: 2 years
Investigators: Multiple
Sites: Multicenter, International
Funding: Biogen, Inc.
Results/Publications: 27% reduction in progression and significantly better QOL in people on
Avonex (Abstract #P06.075, AAN 2002)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a)
Mode of action/purpose of study: Brief cognitive-behavioral intervention to treat self-injection
anxiety in people with MS taking Avonex
Study description: Single blinding, 6-week cognitive intervention administered by nurse vs.
telehealth monitoring
Dose/route: 30 mcg/wk im
Outcome parameters: Ability to self-inject
Type of MS: RR
Number of Subjects: 40
Start date: February 2002
Observation period: 7 months
Investigators: D. Mohr, D. Cox
Sites: University of California, San Francisco
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Open label, addition of Copaxone to ongoing Avonex treatment
Dose/route: Avonex 30 mcg/wk im + Copaxone 20 mg/d sc
Outcome parameters: MRI, clinical
Type of MS: RR
Number of Subjects: 32
Start date: August 1998
Observation period: 6 months with 6-month extension
Investigators: F. Lublin, M. Baier, G. Cutter, C. Bever, R. Elfont, O. Khan, R. Lisak, H. McFarland,
P. Narayana, J. Noseworthy, H. Panitch, M. Weber, J. Whitaker, J. Wolinsky, K. Bashir, K. Johnson
Sites: Mount Sinai Medical Center, New York; Mayo Clinc, Rochester, MN; University of Alabama,
Birmingham; University of Maryland, College Park; Wayne State University, Detroit; Pythagoras,
Inc.
Funding: Biogen, Inc., Teva Neuroscience
Results/Publications: Combination was safe. Hint of efficacy. Full factorial, blinded study in
planning stage. (Neurology 2001;56(suppl):A148; Abstract #S13.003, AAN 2002)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Avonex 30 mcg/wk im + Copaxone 20 mg/d sc vs. Avonex 30 mcg/wk im + PBO vs.
Copaxone 20 mg/d sc PBO
Outcome parameters: Annualized relapse rate, EDSS, MSFC, MSQLI, MRI
Type of MS: RR
Number of Subjects: 750
Start date: Planned
Observation period: 36 months
Investigators: F. Lublin and others
Sites: Mount Sinai Medical Center, New York and others
Funding: Biogen, Inc., Teva Neuroscience
Results/Publications: Not available
Last update: Fall 2002

Agent: Avonex® (interferon beta-1a) and EMLA (lidocaine and prilocaine) anesthetic cream
Mode of action/purpose of study: To improve injection side effects
Study description: Crossover, placebo control
Dose/route: Avonex 30 mcg/wk im + EMLA applied topically 2 hrs before injection q 4 wk vs.
Avonex + PBO q 4 wk
Outcome parameters: Not available
Type of MS: RR, SP
Number of Subjects: 10
Start date: January 2002
Observation period: 8 weeks
Investigators: M. Buhse
Sites: North Shore University Hospital, Manhasset, NY
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and Imuran® (azathioprine)
Mode of action/purpose of study: To affect immune function; also known as ERAZIMUS study
Study description: Open label
Dose/route: Avonex once/wk im + AZA 50, 100, or 150 mg po
Outcome parameters: Clinical and biological safety and tolerance; serial measures of drug
metabolites (6 thioguanine and neopterin)
Type of MS: RR
Number of Subjects: 30
Start date: September 1997
Observation period: 4 months
Investigators: C. Confavreux, T. Moreau, J. Boissel
Sites: Hopital de l'Antiquaille, Lyon, France
Funding: Biogen, Inc., Glaxo Wellcome
Results/Publications: Safe and tolerable (Abstract #P05.099, AAN 2001)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and Imuran® (azathioprine)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Avonex 3 mcg/wk im + Imuran 50-150 mg/d po
Outcome parameters: Safety, duration of attack, frequency of relapse
Type of MS: RR
Number of Subjects: Not available
Start date: April 2001
Observation period: 15 months
Investigators: A. Rae-Grant, J. Greenstein
Sites: Lehigh Valley Hospital, Allentown, PA
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and methotrexate
Mode of action/purpose of study: To affect immune function
Study description: Avonex vs. Avonex + methotrexate
Dose/route: Avonex 30 mcg/wk im + methotrexate 20 mg/wk po vs. Avonex 30 mcg/wk im
Outcome parameters: Serial Gd-MRI; clinical
Type of MS: RR
Number of Subjects: 15
Start date: January 1999
Observation period: 9 months
Investigators: P. Calabresi
Sites: Brown University Medical School, Providence, RI
Funding: Biogen, Inc.
Results/Publications: 44% decrease in Gd-MRI lesions (p=0.02); trends toward improved EDSS,
relapses, steroid use; MSFC stable; nausea only major side effect (Neurology 2002;58:314-317)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and methotrexate
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Avonex 30 mcg/wk sc + methotrexate 2g2 iv q 2 mo x 6; leucovorin rescue po
Outcome parameters: MRI, MSFC, EDSS, frequency of relapse
Type of MS: RR
Number of Subjects: 15
Start date: July 2001
Observation period: 14 months
Investigators: V. Rowe
Sites: MidAmerica Neuroscience Institute, Kansas City
Funding: Biogen, Inc., MidAmerica Neuroscience Research Foundation
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and methylprednisolone vs. Avonex, methylprednisolone and
cyclophosphamide
Mode of action/purpose of study: To affect immune function
Study description: Single blinding
Dose/route: Avonex im, methylprednisolone, cyclophosphamide iv
Outcome parameters: EDSS, MRI, immune parameters
Type of MS: Nonresponders to Avonex
Number of Subjects: 60
Start date: 1998
Observation period: 1 year
Investigators: D. Smith, H. Weiner, M. Olek, D. Dawson, S. Khoury, D. Hafler
Sites: Brigham and Women's Hospital, Boston
Funding: Not available
Results/Publications: Not available
Last update: Spring 2001

Agent: Avonex® (interferon beta-1a) and pain medication (Tylenol® [acetaminophen], Advil®
[ibuprofen] or Aleve® [naproxen])
Mode of action/purpose of study: To improve side effects
Study description: Open label
Dose/route: Avonex 30 mcg/wk im + Tylenol 1 g qid po, Advil 600-800 mg po, Aleve 400 mg bid po
or PBO
Outcome parameters: Fatigue Impact Scale, weekly reports, 3-month neurological exam and
compliance
Type of MS: RR
Number of Subjects: 90
Start date: February 2002
Observation period: 6 weeks-3 months
Investigators: M. Leuschen
Sites: University of Nebraska Medical Center, Omaha
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) vs. Pegolated Intron (interferon alpha)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Avonex 30 mcg/wk im vs. peg intron 1 or 3 mg/kg/wk sc
Outcome parameters: Monthly MRI
Type of MS: RR
Number of Subjects: 240
Start date: 1999
Observation period: 24 weeks
Investigators: M. Clanet, P. Duquette and others
Sites: Hopital Purpan, Toulouse, France; Hopital Notre Dame, Montreal and others
Funding: Schering Plough
Results/Publications: Not available
Last update: Spring 2000

Agent: Avonex® (interferon beta-1a) and prednisone
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Avonex 30 mcg/wk im vs. Avonex 30 mcg/wk im + prednisone 15 mg/d po
Outcome parameters: Relapse, EDSS
Type of MS: RR, SP
Number of Subjects: 55
Start date: Not available
Observation period: 12 months
Investigators: H. Salama
Sites: Indiana Center for MS and Neuroimmunopathologic Disorders, Indianapolis
Funding: Biogen, Inc.
Results/Publications: Combination therapy may have additional treatment effect on proinflammatory
cytokines and T-cell activation; no difference in binding antibodies to beta-IFN (Abstract #P04.123,
AAN 2002)
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) and Prozac® (fluoxetine)
Mode of action/purpose of study: To affect immune function and improve symptoms
Study description: Avonex + Prozac vs. Avonex + placebo, double blinding
Dose/route: Avonex 30 mcg/wk im + Prozac 20 mg po
Outcome parameters: Weekly patient diaries monitoring side effects
Type of MS: RR
Number of Subjects: 20
Start date: February 2000
Observation period: 32 weeks
Investigators: D. Hart
Sites: Upstate Clinical Research, LLC, Albany, NY
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Avonex® (interferon beta-1a) vs. Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Retrospective analysis of patients taking Avonex or Rebif for 15-21 months, and
follow-up of patients for additional three years
Dose/route: Avonex 30 mcg/wk im vs. Rebif 44 mcg tiw sc
Outcome parameters: Long-term effect
Type of MS: RR
Number of Subjects: Not available
Start date: Planned
Observation period: 5 years
Investigators: T.J. Murray and others
Sites: Dalhousie University, Halifax, Canada and others
Funding: Biogen, Inc.
Results/Publications: Not available
Last update: Fall 2002

Agent: AVP-923 (dextromethorphan/quinidine)
Mode of action/purpose of study: To improve symptoms (pseudobulbar effect)
Study description: Double blinding, placebo control
Dose/route: 1 capsule po tid q 12 hr for 12 wks vs. PBO
Outcome parameters: Lability scale, number of episodes recorded in patient diary, Visual Analog
Scale, Pain Intensity Rating Scale
Type of MS: P, RR, with pseudobulbar effect
Number of Subjects: 96
Start date: 12/1/02
Observation period: 3 months
Investigators: Multiple, United States
Sites: Multiple, United States
Funding: Avanir Pharmaceuticals
Results/Publications: Not available
Last update: Winter 2003

Agent: Bee venom
Mode of action/purpose of study: To improve symptoms
Study description: Open label
Dose/route: 4 different doses biw id
Outcome parameters: Safety
Type of MS: Progressive
Number of Subjects: 16
Start date: September 2000
Observation period: 1 year
Investigators: J. Bellanti, J. Richert
Sites: Georgetown University Medical Center, Washington, D.C.
Funding: MSAA
Results/Publications: Not available
Last update: Spring 2001

Agent: Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To affect immune function; also known as BENEFIT study
Study description: Double blinding, placebo control
Dose/route: 250 mcg qod sc
Outcome parameters: Time to definite MS, frequency of relapse, EDSS, MSFC, MRI
Type of MS: First clinical demyelinating event suggestive of MS Number of Subjects: 400
Start date: January 2002
Observation period: 24 months
Investigators: Multiple
Sites: Multicenter, Europe, Canada, Israel
Funding: Schering AG
Results/Publications: Not available
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To define the frequency of thyroid and liver dysfunction and of
autoantibodies during Betaseron treatment; also known as BEST study
Study description: Open label
Dose/route: 250 mcg qod sc
Outcome parameters: Liver/thyroid function, autoantibody serum level, anti-IFN serum antibody
Type of MS: RR
Number of Subjects: 200
Start date: May 1996
Observation period: 1 year
Investigators: L. Durelli, U. Ecari and others
Sites: University of Turin, Italy and others
Funding: Farmades SpA
Results/Publications: Random fluctuations of thyroid alteration and autoAb levels, not correlated
with Rx; liver function alteration peaked at 2-3 months after beginning Rx and decreased thereafter
(Neurology 2001;57(8):1363-70)
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To affect immune function; also known as OPTIMS study
Study description: Radiologist and lab blinding, low dose vs. high dose
Dose/route: 250 mcg qod sc vs. 375 mcg qod sc
Outcome parameters: MRI nonresponders, immune and lab assessments, neutralizing antibody
production
Type of MS: RR
Number of Subjects: 200
Start date: September 1999
Observation period: 1 year
Investigators: L. Durelli and others
Sites: University of Turin, Italy and others
Funding: University of Turin
Results/Publications: Not available (Neurological Sciences 2001;22(2):201-3)
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 250 mcg qod sc
Outcome parameters: EDSS, MSFC, Sickness Impact Profile, MRI, MTR, BRNB
Type of MS: PP, transitional
Number of Subjects: 73
Start date: Not available
Observation period: 2 years
Investigators: X. Montalban, L. Breva, M. Tintore, C. Borras, J. Rio, C. Nos, X. Aymerich, J.
Alonso, R. Horno, M. Vicente, A. Rovira
Sites: Vall d'Hebron University Hospitals, Barcelona, Spain
Funding: Not available
Results/Publications: Confirmed progression at 3 months in 27.8% (Betaseron) and 37.8%
(placebo); T2 (p=0.006) and T1 (p=0.001) lesion load and number of active lesions (p=0.005)
significantly better in Betaseron group (Abstract #P06.089, AAN 2002)
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b) and Imuran® (azathioprine)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Betaseron 250 mcg qod sc for 3 mo + AZA 2 mg/kg/d po for 6 mo
Outcome parameters: Safety
tolerability, Gd-MRI, EDSS, MSFC, labs
Type of MS: RR, SP
Number of Subjects: 18
Start date: October 1999
Observation period: 9 months
Investigators: P. Calabresi
Sites: Rhode Island Hospital, Providence; Brown University, Providence; University of Maryland,
College Park
Funding: Berlex
Results/Publications: Not available
Last update: Spring 2000

Agent: Betaseron® (interferon beta-1b) and Imuran® (azathioprine)
Mode of action/purpose of study: To affect immune function
Study description: Open label assessment of people who had not responded to Betaseron alone
Dose/route: Not available
Outcome parameters: MRI, EDSS
Type of MS: RR
Number of Subjects: 6
Start date: Not available
Observation period: 35 months
Investigators: S. Markovic-Plese and others
Sites: NINDS
Funding: NINDS
Results/Publications: Combination provided synergistic effect on stabilizing blood brain barrier, as
demonstrated by decreased Gd-enhancing lesions (Abstract #S62.002, AAN 2002)
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b) vs. Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as INCOMIN study
Study description: MRI blinding, lab blinding
Dose/route: Betaseron 250 mcg qod sc vs. Avonex 30 mcg/wk im
Outcome parameters: Cytokine serum levels, cell adhesion molecules, liver/thyroid function,
autoantibody serum levels
Type of MS: RR
Number of Subjects: 188
Start date: October 1997
Observation period: 2 years
Investigators: L. Durelli and others
Sites: University of Turin, Italy and others
Funding: Italian Ministry of Health, Italian MS Society
Results/Publications: Betaseron reduced disease activity (relapse rate, EDSS, MRI) more effectively
than Avonex, during the second year of follow-up (Abstract #S13.004, AAN 2002)
Last update: Spring 2002

Agent: Betaseron® (interferon beta-1b) vs. Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function; also known as BEYOND study
Study description: Double blinding, low dose vs. high dose vs. Copaxone
Dose/route: Betaseron 500 mcg qod sc vs. Betaseron 250 mcg qod sc vs. Copaxone 20 mg/d sc
Outcome parameters: Proportion of relapse-free patients
Type of MS: RR
Number of Subjects: 2000
Start date: September 2002
Observation period: 2 years
Investigators: S.C. Cook and others
Sites: University of Medicine & Dentistry of New Jersey, and others, international
Funding: Schering AG
Results/Publications: Not available
Last update: Fall 2002

Agent: BMS 188667 (CTLA4-Ig)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 2 mg/kg/mo iv, 10 mg/kg/mo iv or PBO/mo iv
Outcome parameters: MRI, relapses
Type of MS: RR
Number of Subjects: 330
Start date: January 2002
Observation period: 10 months
Investigators: Multiple
Sites: Multicenter, International
Funding: Bristol-Myers Squibb Company
Results/Publications: Not available
Last update: Spring 2002

Agent: Bone marrow/peripheral stem cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Cyclophosphamide 60 mg/kg iv in 250 ml DSW over 1 hour on d -6,-5, TBI w
lungshield, 150 cGy bid on d -3,-2,-1
Outcome parameters: EDSS, Scripps NRS, Gd-MRI, CSF immunoglobulins, cell counts
Type of MS: Progressive
Number of Subjects: 20
Start date: October 1996
Observation period: 5 years
Investigators: R. Burt, B. Cohen, F. Davis, D. Stefoski, K. Karlin, A. Tranor, L. Lobeck, W. Burns
Sites: Northwestern Memorial Hospital, Evanston, IL; Rush-Presbyterian-St Luke's Hospital,
Chicago; Medical College of Wisconsin, Milwaukee
Funding: Not available
Results/Publications: 13 patients treated without unexpected adverse effects; as of Spring 2000
update, no post-Rx disease progress or Gd-MRI lesions; 12 with no new non-enhancing MRI lesions
(Blood 1998;92:3505-3514)
Last update: Spring 2000

Agent: Bone marrow/peripheral stem cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Open label, single arm
Dose/route: Total body irradiation 2 Gy x 4, cyclophosphamide 60 mg/kg x 2, equine anti-thymocyte
globulin 15 mg/kg/d x 6 iv
Outcome parameters: EDSS, NRS, MRI
Type of MS: SP, PR
Number of Subjects: 10
Start date: Fall 2002
Observation period: 3 years
Investigators: H. Openshaw, R. Nash
Sites: City of Hope National Medical Center, Duarte, CA; Fred Hutchinson National Cancer Center,
Seattle
Funding: Institutional and private funding
Results/Publications: Not available
Last update: Spring 2002

Agent: Bone marrow/peripheral stem cell transplantation vs. Novantrone® (mitoxantrone for
injection concentrate)
Mode of action/purpose of study: To affect immune function
Study description: Stem cell transplantation vs. Novantrone
Dose/route: Immune ablation and hematopoietic stem cell rescue vs. Novantrone
Outcome parameters: MRI, clinical, neuropsychological testing
Type of MS: SP
Number of Subjects: 92
Start date: September 2000
Observation period: 5 years
Investigators: L. Lobeck, W. Burns, R. Burt, R. Cohen
Sites: Medical College of Wisconsin, Milwaukee; Northwestern University, Evanston, IL
Funding: NIAID
Results/Publications: Not available
Last update: Spring 2001

Agent: Bone marrow/peripheral stem cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Prednisone 1 mg/kg/d po, GCSF 15 mcg/kg/d sc for PBsc mobliz, TBI 2 Gy x 4,
cyclophosphamide 60 mg/kg x 2, horse antithymocyte globulin 15 mg/kg/d x 6, GCSF 5 mcg/kg/d iv
post pBsc infusion
Outcome parameters: Progression of disability
Type of MS: RR, SP, PP
Number of Subjects: 35
Start date: Ongoing
Observation period: 3 years
Investigators: R. Nash, S. Pavletic, P. McSweeney, J. DiPersio, S. Forman
Sites: Fred Hutchinson Cancer Research Center, Seattle; University of Nebraska, Omaha; University
of Colorado Health Sciences Center, Denver; Washington University, St. Louis; City of Hope
National Medical Center, Duarte, CA
Funding: Not available
Results/Publications: 26 pts as of 2000, with 6 mo mean follow-up; stable (7), increased EDSS (6),
decreased EDSS (5), new or enhancing MRI lesions at 1 year (2), death (1) (Abstract #S23.001, AAN
2002; Abstract, American Society of Hematology 2000)
Last update: Spring 2002

Agent: Bone marrow/peripheral stem cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Busulfan 1 mg/kg po (x 16 over 5 d), cytoxan 60 mg/kg/d iv over 2 d, antithymocyte
globulin 10 mg/kg/d iv over 3 d, autologous CD34+ cells >= 2 million kg
Outcome parameters: EDSS, MRI, CSF
Type of MS: SP, PP
Number of Subjects: 15
Start date: March 1997
Observation period: 3 years
Investigators: H. Openshaw, S. Forman
Sites: City of Hope National Medical Center, Duarte, CA
Funding: Amgen, Inc., Institutional funding
Results/Publications: Not available
Last update: Spring 2000

Agent: Bone marrow/peripheral stem cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Treated patients vs. untreated patients
Dose/route: Not available
Outcome parameters: Clinical, MRI, immune function
Type of MS: Rapidly progressive
Number of Subjects: 24
Start date: February 2001
Observation period: 6 months
Investigators: M. Freedman and others
Sites: University of Ottawa; University of Toronto; McGill University; Hopital Notre Dame
Funding: MS Research Foundation, MS Society of Canada
Results/Publications: GCSF use safe after high-dose cyclophosphamide (Abstract #P06.077, AAN
2002)
Last update: Spring 2002

Agent: Bone marrow/peripheral stem cell transplantation)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Not available
Outcome parameters: EDSS, MRI
Type of MS: Severely progressive
Number of Subjects: 10
Start date: January 1998
Observation period: 1-2 years
Investigators: D. Karussis, O. Abramsky, S. Slavin
Sites: Hadassah Hospital, Jerusalem, Israel
Funding: Not available
Results/Publications: Not available
Last update: Spring 1998

Agent: Bone marrow/peripheral stem cell transplantation)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Cyclophosphamide, G-CSF, Apheresis
Outcome parameters: EDSS, ambulation, nine hole PEG test, PASAT, MRI, SSF-36, BMT-HAQ,
NRS
Type of MS: Active MS despite at least 3 mo interferon
Number of Subjects: 50-75
Start date: Not available
Observation period: 5 years
Investigators: R. Burt, B. Cohen, L. Lobeck, C. Bredeson
Sites: Northwestern University, Evanston, IL; International Bone Marrow Transplant Registry,
Milwaukee; Medical College of Wisconsin, Milwaukee
Funding: Not available
Results/Publications: Not available
Last update: Fall 2002

Agent: Bone marrow/peripheral stem cell transplantation)
Mode of action/purpose of study: To affect immune function
Study description: Open label, MRI results
Dose/route: Cyclophosphamide, G-CSF, BEAM, Busulphan
Outcome parameters: MRI
Type of MS: Worsening RR, progressive
Number of Subjects: 35
Start date: Not available
Observation period: Not available
Investigators: V.K. Kimiskidis and others
Sites: Aristotle University of Thessaloniki, Greece
Funding: Not available
Results/Publications: G-CSF associated in some patients with radiological deterioration, stem cell
therapy causes profound and long-lasting suppression, but not elimination of subclinical pathological
MRI activity (Abstract, 12th Meeting of European Neurological Society)
Last update: Fall 2002

Agent: Campath® (alemtuzumab)
Mode of action/purpose of study: To affect immune function
Study description: Retrospective study
Dose/route: Group 1 - Campath started at mean of 11 and 4 yr after disease onset and progression,
respectively; Group 2 - Campath given at a mean of 21 mo after disease onset
Outcome parameters: EDSS, relapse rate, MRI
Type of MS: RR, SP
Number of Subjects: 47
Start date: Not available
Observation period: Not available
Investigators: E. Le Page, A. Coles, A. Cox, V. Denys, D. Miller, A. Compston
Sites: University of Cambridge, UK, and others, Europe
Funding: Not available
Results/Publications: Change in annualized relapse rate from 2.9 to 0.3, 12-15 mo after Campath in
RR MS (Abstract, 12th Meeting of European Neurological Society)
Last update: Fall 2002

Agent: Campath® (alemtuzumab) vs. Rebif® (interferon beta-1a)
Mode of action/purpose of study: To improve immune function; also known as CAMMS221 study
Study description: High-dose Campath vs. low-dose Campath vs. Rebif, physician blinding
Dose/route: Campath 1.5 mg/kg iv over 3 d, 0.9 mg/kg over 3 d a year later, 0.9 mg/kg over 3 d after
two years) vs. Campath 0.5 mg/kg iv over 5 d, 0.3 mg/kg over 3 d a year later, 0.3 mg/kg over 3 d
after 2 years vs. Rebif 44 mcg sc tiw
Outcome parameters: Sustained increase in disability by EDSS, cerebral atrophy on MRI
Type of MS: RR
Number of Subjects: 120
Start date: March 2002
Observation period: 3 years, extended follow-up for 2 more years
Investigators: A. Compston,
A. Coles
Sites: University of Cambridge, UK; Frenchay Hospital, Bristol, UK; Walton Centre for Neurology,
Liverpool, UK; Royal Victoria Infirmary, Newcastle, UK
Funding: Millennium & ILEX Partners, L.P.
Results/Publications: Not available (Lancet 1999 Nov 13;354(9191):1691-5, Annals of Neurology
1999 Sep;46(3):296-304)
Last update: Spring 2002

Agent: Cannabis extract vs. tetrahydrocannabinol (marijuana derivatives)
Mode of action/purpose of study: To improve symptoms
Study description: Two types of cannabis treatment vs. placebo control
Dose/route: Capsular cannabis po, tetrahydrocannabinol or PBO
Outcome parameters: Effect on spasticity
Type of MS: Not available
Number of Subjects: 660
Start date: December 1999
Observation period: Not available
Investigators: J. Zajicek
Sites: Derriford Hospital, Plymouth, UK
Funding: Medical Research Council, UK
Results/Publications: Not available
Last update: Spring 2000

Agent: Cannabis extract vs. tetrahydrocannabinol (marijuana derivatives)
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding, placebo control, crossover
Dose/route: Synthetic dranabidol (tetrahydrocannabinol; Marinol) up to 5 mg bid po or cannabis
plant extract (Cannador) up to 5 mg bid vs. PBO
Outcome parameters: Ashworth Spasticity Scale, EDSS, MSFC, QOL
Type of MS: Severe spasticity
Number of Subjects: 16
Start date: 1999
Observation period: 10 weeks
Investigators: C. Polman, J. Killestein
Sites: Free University Medical Centre, Amsterdam
Funding: Internal funds
Results/Publications: No significant benefit of treatment (Abstract #0-35, ECTRIMS 2001)
Last update: Spring 2002

Agent: Cannabis oil vs. tetrahydrocannabinol (marijuana derivatives)
Mode of action/purpose of study: To improve symptoms
Study description: Two types of cannabis treatment vs. placebo control
Dose/route: Cannabis oil vs. tetrahydrocannabinol vs. PBO po
Outcome parameters: Pain, tremor
Type of MS: With pain and tremor
Number of Subjects: 20
Start date: January 2001
Observation period: 3 months, with optional 9-month
extension
Investigators: P. Fox
Sites: Derriford Hospital, Plymouth, UK
Funding: Medical Research Council, UK
Results/Publications: Not available
Last update: Spring 2001

Agent: CellCept® (mycophenolate mofetil)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 3 d methylprednisone, then 1 yr CellCept 2gm/day po vs. 3 d methylprednisone, then 1
yr PBO
Outcome parameters: MRI
Type of MS: Active MS despite first-line therapy
Number of Subjects: 12
Start date: Not available
Observation period: 1 year
Investigators: D.R. Smith, S. L. Cook, B. I. Glanz, C. Guttmann, S. J. Khoury
Sites: Brigham & Women's Hospital, Boston; Massachusetts General Hospital, Boston
Funding: Roche Pharmaceuticals, USA, National Institutes of Health
Results/Publications: 6 completed study; 5 attacks (in CellCept-treated patients), 6 (in PBO
patients); gd-enhancing lesions in 0/6 (CellCept), 2/4 (PBO) at termination; change in T2 lesion
burden +.28 (CellCept), +.05 (PBO); treated patients (Abstract, CMSC 2002)
Last update: Fall 2002

Agent: CellCept® (mycophenolate mofetil) and Betaseron® (interferon beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Open label, placebo control
Dose/route: Not available
Outcome parameters: Not available
Type of MS: RR
Number of Subjects: 30
Start date: Not available
Observation period: Not available
Investigators: D. Mikol
Sites: University of Michigan, Ann Arbor
Funding: Berlex
Results/Publications: Not available
Last update: Spring 2002

Agent: CNTO 1275 (monoclonal antibody)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Not available
Outcome parameters: Not available
Type of MS: Not available
Number of Subjects: Not available
Start date: Not available
Observation period: Not available
Investigators: Not available
Sites: Yale University, New Haven, CT
Funding: Centocor, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function; also known as PROMISE study
Study description: Double blinding, placebo control
Dose/route: 20 mg/d sc
Outcome parameters: Time to confirmed progression, composite rating scale, MRI, safety
Type of MS: PP
Number of Subjects: 900
Start date: 2000
Observation period: 3 years
Investigators: J. Wolinsky and others
Sites: University of Texas Health Sciences Center, Houston and others in U.S. and Canada
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Terminated prematurely; interim analysis showed that improbable that the
study would reach statistical significance (Teva Pharmaceutical Industries, Ltd., press release,
11/7/02)
Last update: Winter 2003

Agent: Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 20 mg/d sc
Outcome parameters: New enhancing lesions on standard versus triple dose Gd-enhanced MRI
scans
Type of MS: RR
Number of Subjects: 30
Start date: October 1999
Observation period: 12 months
Investigators: M. Filippi, G. Comi
Sites: San Raffaele Scientific Institute, Milan, and others
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Drug had graduated effect on MS inflammatory activity and significantly
reduced mean numbers of enhancing lesions per patient per month on both standard and triple-dose
scans (Neurology 2002;59:1429-1432)
Last update: Winter 2003

Agent: Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 20 mg/d sc
Outcome parameters: Relapse rate, percentage relapse free, EDSS, MSFC
Type of MS: RR
Number of Subjects: 120
Start date: January 2001
Observation period: 1 year
Investigators: F. Lublin, A. Miller and others
Sites: Mount Sinai School of Medicine, New York, and others
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Not available
Last update: Spring 2001

Agent: Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Prospective, open label, multi-year follow-up of patients in original study
Dose/route: 20 mg/d sc
Outcome parameters: EDSS
Type of MS: RR
Number of Subjects: 142
Start date: 1991
Observation period: Ongoing
Investigators: K. Johnson and others
Sites: Multicenter, U.S.
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Yearly MS relapse rate has fallen to approx. 1 in 5 years, % of patients
worsening is low; reduced clinical effect in those who received PBO in first 30 mo (Abstract
#P06.079, AAN 2002)
Last update: Spring 2002

Agent: Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Placebo control, to assess development of new lesions evolving into "black holes"
Dose/route: 20 mg/d sc
Outcome parameters: New lesions, black holes
Type of MS: RR
Number of Subjects: 239
Start date: Not available
Observation period: 9 months
Investigators: M. Filippi and others
Sites: Multicenter, International
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Percentage of new lesions that evolved into "black holes" was lower in
Copaxone-treated group at 7 (p=0.04) and 8 (p=0.002) mo after lesion appearance (Neurology
2001;57:731-733)
Last update: Spring 2002

Agent: Copaxone® (glatiramer acetate), oral
Mode of action/purpose of study: To affect immune function; also known as CORAL study
Study description: Double blinding, placebo control
Dose/route: 5 mg po vs. 50 mg po vs. PBO
Outcome parameters: Relapse rate, MRI, EDSS, FS
Type of MS: RR
Number of Subjects: 1300
Start date: Spring 2000
Observation period: 56 weeks
Investigators: Multiple
Sites: Multicenter, International
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Trend for treatment effect for higher dose not statistically significant at interim
analysis (Teva Pharmaceutical Industries, Ltd., press release, 9/14/01)
Last update: Spring 2002

Agent: Copaxone® (glatiramer acetate) and Proventil® (albuterol)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Copaxone 20 mg/d sc + albuterol 4 mg/d po, or Copaxone 20 mg/d sc + PBO
Outcome parameters: MSFC, IL-13 and IFN (secreted by Copaxone-reactive T cell lines), time to
relapse, number and severity of relapses, MRI, clinical scales, change in cytokine secretions and
change in percentage of IL-12-producing monocytes
Type of MS: Not available
Number of Subjects: 40
Start date: September 2001
Observation period: 2 years of follow-up
Investigators: S. Khoury
Sites: Brigham and Women's Hospital MS Center, Boston
Funding: NIH, NIAID, Autoimmunity Centers of Excellence
Results/Publications: Not available
Last update: Spring 2002

Agent: Copaxone® (glatiramer acetate) vs. Avonex® (interferon beta-1a) vs. Betaseron® (interferon
beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Prospective, open label
Dose/route: Avonex 30 mcg im/wk vs. Betaseron 250 mcg qod sc vs. Copaxone 20 mg/d sc
Outcome parameters: Relapse rate, EDSS, proportion of relapse-free patients
Type of MS: RR
Number of Subjects: 156
Start date: Not available
Observation period: 18 months
Investigators: O. Khan
Sites: Wayne State University, Detroit
Funding: Teva Pharmaceutical Industries, Ltd.
Results/Publications: Mean annualized number of relapses significantly reduced in Copaxone
(p>0.0001) and Betaseron (p=0.001) groups, not in Avonex group (p=0.106) (Multiple Sclerosis
2001;7:349-353)
Last update: Spring 2002

Agent: Cyclophosphamide
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: iv
Outcome parameters: EDSS
Type of MS: Rapidly progressive
Number of Subjects: 14
Start date: Not available
Observation period: 36 months
Investigators: O. Khan and others
Sites: Wayne State University, Detroit
Funding: National MS Society, Wayne State University Neuroscience Program
Results/Publications: Mean EDSS dropped from 6.6 to 4.78 at 36 months, well tolerated (Abstract
#S23.002, AAN 2002)
Last update: Spring 2002

Agent: Estriol
Mode of action/purpose of study: To affect immune function
Study description: Crossover
Dose/route: 8 mg/d po
Outcome parameters: MRI, blood immune studies
Type of MS: RR, SP
Number of Subjects: 12
Start date: April 1999
Observation period: 2 years
Investigators: R. Voskuhl, N. Sicotte, A. Wu
Sites: University of California, Los Angeles
Funding: National MS Society
Results/Publications: RR subjects demonstrated significant decreases in DTH responses to tetanus,
IFN-gamma levels in PBMCs, and Gd-enhancing lesion numbers and volumes on monthly MRI
(Abstract #S11.002, AAN 2001)
Last update: Spring 2002

Agent: Fampridine (4-aminopyridine, 4-AP)
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding, placebo control
Dose/route: 0-4 mg bid po
Outcome parameters: Safety, tolerability, pilot efficacy measures
Type of MS: A score of 6.5 or less on the EDSS
Number of Subjects: 120
Start date: January 2001
Observation period: 14 weeks
Investigators: A. Goodman, J. Cohen, T. Vollmer, and others
Sites: University of Rochester, NY; Cleveland Clinic Foundation; Yale MS Center, New Haven, CT
Funding: Acorda Therapeutics
Results/Publications: Not available
Last update: Spring 2001

Agent: Ginkgo biloba
Mode of action/purpose of study: To improve cognitive function
Study description: Not available
Dose/route: Not available
Outcome parameters: Cognitive rehabilitation
Type of MS: SP
Number of Subjects: Not available
Start date: Planned
Observation period: planned
Investigators: W. Tyor
Sites: Medical University of South Carolina, Charleston
Funding: Not available
Results/Publications: Not available
Last update: Spring 2001

Agent: Ginkgo biloba
Mode of action/purpose of study: To improve cognitive function
Study description: Double blinding, placebo control, crossover
Dose/route: 240 mg/d
Outcome parameters: Extensive neuropscychological battery, including Paced Auditory Serial
Addition Test, California Verbal Learning Test and Delis-Kaplan Executive Measures Scale, BDI,
MSQLI and MFIS
Type of MS: Mild MS
Number of Subjects: 23
Start date: Not available
Observation period: 6 months
Investigators: C. Kenney and others
Sites: University of California, San Diego
Funding: University of California, San Diego
Results/Publications: No adverse events; significant improvements in PASAT, MSCQLI in patients
on ginkgo; significant correlations self-reported between cognitive ability and fatigue (Abstract
#P06.081, AAN 2002)
Last update: Spring 2002

Agent: IDEC-131 (anti-CD40L or anti-CD154)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, crossover
Dose/route: 15 mg/kg x 8 (q o wk x 5, q mo x 3) iv
Outcome parameters: MRI, EDSS, MSFC, NMR, Mag T, biologics, cognitive
Type of MS: RR
Number of Subjects: 46
Start date: January 2002
Observation period: 22 months
Investigators: L. Kasper, K. Ryan, R. Noelle, C. Fadul
Sites: Dartmouth Medical School, Hanover, NH
Funding: NINDS, Immune Tolerance Network
Results/Publications: Safety risk of thromboembolism identified and all studies halted (IDEC
Pharmaceuticals press release, June 10, 2002)
Last update: Fall 2002

Agent: Immunoglobulin
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1 g/kg iv
Outcome parameters: Neurological exam
Type of MS: SP
Number of Subjects: 12
Start date: February 1998
Observation period: 27 months
Investigators: R. Medaer
Sites: Dr. L. Willems-Instituut, Diepenbeek, Belgium
Funding: Bayer AG
Results/Publications: Not available
Last update: Spring 2000

Agent: Immunoglobulin
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1 g/kg/mo iv
Outcome parameters: Recovery of targeted deficits, change in EDSS
Type of MS: RR
Number of Subjects: 172
Start date: September 2000
Observation period: 6 months
Investigators: P. Sorensen and others
Sites: Multiple sites
Funding: Bayer AG
Results/Publications: Not available
Last update: Spring 2002

Agent: Immunoglobulin
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 0.4 g/kg/d iv q 4 wk x 8
Outcome parameters: EDSS, Functional Status, Ambulation Index, hematology, biochemistry, MRI,
visual function testing
Type of MS: With optic neuritis
Number of Subjects: 55
Start date: Not available
Observation period: 12 months
Investigators: J. Noseworthy and others
Sites: Mayo Clinic and Mayo Foundation, Rochester, MN and Scottsdale, AZ
Funding: National Eye Institute, Bayer Pharmaceuticals, Inc.
Results/Publications: Terminated due to negative results; improvement in visual scores not observed
at 6 mo (Neurology 2001;56:1514-1522)
Last update: Spring 2002

Agent: Immunoglobulin
Mode of action/purpose of study: To affect immune function; also known as ESIMS study
Study description: Double blinding, placebo control
Dose/route: 1 g/kg/mo iv
Outcome parameters: Progression on EDSS, frequency of relapse, MRI
Type of MS: SP
Number of Subjects: 210
Start date: September 1997
Observation period: 30 months
Investigators: O. Hommes and others
Sites: Multicenter, Europe and Canada
Funding: Bayer AG
Results/Publications: No difference found between groups on primary and secondary endpoints
(Abstracts, 12th meeting of European Neurological Society)
Last update: Fall 2002

Agent: Immunoglobulin and methylprednisolone
Mode of action/purpose of study: To affect immune function; also known as TARIMS study
Study description: Double blinding, placebo control
Dose/route: Ig-C (Bayer 10%) 1 g/d x 3 iv + MePr 1 g/d x 3 iv
Outcome parameters: Mean change in z scores of most affected targeted deficits; mean change in
MSIS, FSS, EDSS, GNDS
Type of MS: In relapse
Number of Subjects: 150
Start date: October 2000
Observation period: 6 months
Investigators: P. Sorensen and others in Scandinavia
Sites: University Hospital, Copenhagen, and others in Scandinavia
Funding: Bayer AG
Results/Publications: Not available
Last update: Spring 2001

Agent: Imuran® (azathioprine)
Mode of action/purpose of study: To affect immune function
Study description: Open label, physician blinding
Dose/route: 2.5-3 mg/kg/d po
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 14
Start date: 1997
Observation period: 2 years
Investigators: L. Massacesi
Sites: Universita di Firenze, Italy
Funding: Italian Ministry of Health
Results/Publications: Safe, active in decreasing brain inflammatory activity and lesion accumulation
at dosage that decreases blood lymphocyte counts (Abstract #S08.002, AAN 2000)
Last update: Spring 2002

Agent: Imuran® (azathioprine) and Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Open label, physician blinding
Dose/route: Imuran 2.5-3 mg/kg/d po + Rebif 11 mcg tiw sc vs. Rebif 22 mcg tiw sc
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 22
Start date: 1997
Observation period: 18 months
Investigators: L. Massacesi
Sites: Universita di Firenze, Italy
Funding: Italian Ministry of University and Research
Results/Publications: Not available
Last update: Spring 2002

Agent: Imuran® (azathioprine) vs. Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Open label, physician blinding
Dose/route: Imuran 2.5-3 mg/kg/d po vs. Rebif 22 mcg tiw sc
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 44
Start date: 1999
Observation period: 2 years
Investigators: L. Massacesi
Sites: Universita di Firenze, Italy
Funding: Italian Ministry of University and Research
Results/Publications: Not available
Last update: Spring 2002

Agent: Inosine
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Not available
Outcome parameters: Newly active lesions
Type of MS: RR
Number of Subjects: 30
Start date: Not available
Observation period: Not available
Investigators: C. Markowitz
Sites: University of Pennsylvania, Philadelphia
Funding: Thomas Jefferson University
Results/Publications: Not available
Last update: Spring 2002

Agent: Insulin-like growth factor-1 (IGF-1)
Mode of action/purpose of study: To affect immune function
Study description: Open label, crossover
Dose/route: 50 mg bid sc for 2 mo
Outcome parameters: MRI, MTRH, A, EDSS, SNRS, Ambulatory Index, nine-hole peg test
Type of MS: RR, SP
Number of Subjects: 7
Start date: Not available
Observation period: 48 weeks
Investigators: J. Frank and others
Sites: NIH, Bethesda, MD
Funding: Cephalon, Inc.
Results/Publications: Did not alter course of disease, well tolerated (Multiple Sclerosis 2002;8:24-
29)
Last update: Spring 2002

Agent: Interferon tau
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 4 doses po
Outcome parameters: Safety
Type of MS: RR
Number of Subjects: 16
Start date: March 1999
Observation period: 1 month
Investigators: M. Olek, H. Weiner, D. Smith, S. Khoury
Sites: Brigham and Women's Hospital, Boston
Funding: Pepgen Corporation
Results/Publications: No clinically significant toxicity; headache most frequent adverse event; 1 pt
had liver enzyme elevation which normalized when dose lowered (Abstract #S11.005, AAN 2001)
Last update: Spring 2002

Agent: Kineret™ (anakinra, interleukin-1 receptor blocker)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1 mg/kg bid sc for 6 mo
Outcome parameters: MRI, EDSS, relapse frequency
Type of MS: RR. SP
Number of Subjects: 84
Start date: January 2000
Observation period: 6 months
Investigators: Multiple
Sites: Multicenter, International
Funding: Amgen, Inc.
Results/Publications: Not available
Last update: Spring 2001

Agent: Low-fat diet with fatty acid supplementation
Mode of action/purpose of study: To improve quality of life
Study description: Single blinding, placebo control
Dose/route: Group 1 - total fat <15% of daily calories with 6 fish oil capsulesd; Group 2 - total fat
<30% of daily calories with PBO supplements
Outcome parameters: SF 36, MFIS, Mental Health Inventory, EDSS, relapse frequency, ELISA
Type of MS: RR
Number of Subjects: Not available
Start date: Not available
Observation period: 1 year
Investigators: B. Weinstock-Guttman and others
Sites: State University of New York at Buffalo, AMC Cancer Research Center, Denver, Colorado,
Cleveland Clinic Foundation, Cleveland, Ohio
Funding: National MS Society, Mellen Center-Cleveland Clinic Foundation
Results/Publications: Preliminary analysis (23 pts) indicates significant decrease in number of
relapses, less disease progression, and decrease in ICAM-1 and PGE2 in very low-fat diet group
(Abstract #P06.090, AAN 2002)
Last update: Spring 2002

Agent: Lymphocytapheresis (removal of immune cells), Imuran® (azathioprine) and prednisone
Mode of action/purpose of study: To affect immune function
Study description: Comparison with "best standard of care"
Dose/route: Year 1 - LCP tiw for 2-3 mo, qow for 2-3 mo to achieve depletion, + AZA, + Pred; year
2 - LCP q 4 wk + AZA 2.5 mg/kg po + Pred 15 mg qod po, then wean
Outcome parameters: EDSS, MRI, QOL, physician/patient global assessment, safety
Type of MS: SP
Number of Subjects: 42
Start date: Planned
Observation period: 3 years
Investigators: A. Reder and others
Sites: University of Chicago and others
Funding: Private funding
Results/Publications: Not available
Last update: Spring 2000

Agent: ME 98 150-302005 (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Not available
Dose/route: po
Outcome parameters: Not available
Type of MS: Not available
Number of Subjects: 160
Start date: September 1999
Observation period: 6 months
Investigators: M. Clanet and others
Sites: Hopital Purpan, Toulouse, France and others
Funding: Not available
Results/Publications: Negative results, publication pending
Last update: Spring 2000

Agent: Mesopram
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: po
Outcome parameters: MRI
Type of MS: RR, SP
Number of Subjects: 30
Start date: March 2001
Observation period: Up to 1 year
Investigators: P. O'Connor and others
Sites: St. Michael's Hospital, Toronto and others in Canada
Funding: Berlex Canada
Results/Publications: Not available
Last update: Spring 2001

Agent: Methylprednisolone
Mode of action/purpose of study: To affect immune function
Study description: Single blinding
Dose/route: 1 g/d x 5 (regular pulses or only for relapses)
Outcome parameters: MRI, EDSS, relapse-related variables
Type of MS: RR
Number of Subjects: 88
Start date: Not available
Observation period: 5 years
Investigators: R. Zivadinov and others
Sites: University of Trieste, Italy; Cleveland Clinic Foundation
Funding: Not available
Results/Publications: Slows development of T1 black holes, prevents or delays whole-brain atrophy
and disability progression (Neurology 2001;57:1239-1247)
Last update: Spring 2002

Agent: Methylprednisolone
Mode of action/purpose of study: To affect immune function
Study description: Single blinding, oral vs. intravenous
Dose/route: 1 g/d x 5 iv or po
Outcome parameters: Brain MRI, duration and severity of attack
Type of MS: Acute attacks during relapse
Number of Subjects: 40
Start date: April 2002
Observation period: 4 weeks
Investigators: G. Comi, V. Martinelli, M. Rodegher, M. Filippi
Sites: San Raffaele Scientific Institute, Milan, and others
Funding: Italian MS Society
Results/Publications: Not available
Last update: Spring 2002

Agent: Modiodal (modafinil)
Mode of action/purpose of study: To improve fatigue
Study description: Double blinding, placebo control
Dose/route: 200-400 mg/d po
Outcome parameters: Fatigue scales
Type of MS: RR, SP
Number of Subjects: 100
Start date: January 2001
Observation period: 6 weeks
Investigators: M. Clanet
Sites: Multicenter, France
Funding: Lafon Laboratories
Results/Publications: Not available
Last update: Spring 2002

Agent: Mycophenolic acid
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1g bid po
Outcome parameters: Relapse rate, EDSS
Type of MS: RR, SP
Number of Subjects: 30
Start date: October 1999
Observation period: 1 year
Investigators: D. Smith, H. Weiner, M. Olek, S. Khoury
Sites: Massachusetts General Hospital, Boston; Brigham and Women's Hospital, Boston
Funding: Not available
Results/Publications: Not available
Last update: Spring 2000

Agent: Neurontin® (gabapentin)
Mode of action/purpose of study: To improve tremor
Study description: Single blinding, crossover, placebo control
Dose/route: Neurontin 1600 mg po vs. 2400 mg vs. PBO
Outcome parameters: Tremor Clinical Rating Scale
Type of MS: With cerebellar tremor
Number of Subjects: 5
Start date: Not available
Observation period: 14 weeks
Investigators: C Bakhos and others
Sites: Hôtel-Dieu de France, Beirut, Lebanon
Funding: Not available
Results/Publications: 2 pts reported marked functional improvement; 2 withdrew (worsening
hypotonia and somnolence); improvement on scale not clinically significant (Abstract #P06.083,
AAN 2002)
Last update: Spring 2002

Agent: NeuroVax™ (T cell receptor peptide, V beta 5.26.513.1)
Mode of action/purpose of study: To affect immune function
Study description: intramuscular vs. intradermal vs. placebo
Dose/route: im vs. id vs. pbo
Outcome parameters: Safety, immune responses, neurologic evaluation, MRI
Type of MS: Not available
Number of Subjects: 60
Start date: November 2000
Observation period: Not available
Investigators: D. Bourdette
Sites: Oregon Health Sciences University, Portland
Funding: The Immune Response Corporation
Results/Publications: Based on interim results (20 pts), which confirm that primary endpoint met
(p=0.0004), all patients enrolled will receive NeuroVax (The Immune Response Corporation press
release, 2/27/02)
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate)
Mode of action/purpose of study: To improve immune function; also known as RENEW study
Study description: Registry to evaluate open-label therapy
Dose/route: 12 mg2 q 3 mo up to a cumulative dose of 140 mg2 iv
Outcome parameters: Drug-related adverse events, tests of lVF, menstrual history, relapse rate
Type of MS: Worsening RR, and SP
Number of Subjects: 500
Start date: February 2001
Observation period: 5 years
Investigators: Multiple
Sites: Multicenter
Funding: Immunex Corporation
Results/Publications: Not available
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate)
Mode of action/purpose of study: To assess quality of life and cost of disease in people with MS
treated with Novantrone in RENEW study
Study description: Prospective study
Dose/route: Not available
Outcome parameters: SF12, HUI, PDDS
Type of MS: RR, SP
Number of Subjects: Not available
Start date: Based on enrollment in RENEW study
Observation period: 5 years
Investigators: T. Vollmer
Sites: Yale University School of Medicine, New Haven, CT
Funding: Immunex Corporation
Results/Publications: Not available
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: q 3 mo iv
Outcome parameters: EDSS, 9HPT, MRI lesion load, brain atrophy
Type of MS: PP
Number of Subjects: 54
Start date: 1998
Observation period: 2 years
Investigators: S. Zamvil, M. Kita, R. Fox
Sites: University of California, San Francisco; Virginia Mason Medical Center, Seattle
Funding: Immunex Corporation
Results/Publications: Not available
Last update: Spring 2001

Agent: Novantrone® (mitoxantrone for injection concentrate)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 5 mg iv
Outcome parameters: EDSS, relapse rate, MRI
Type of MS: SP, PR
Number of Subjects: 30
Start date: August 2000
Observation period: 2 years
Investigators: L. Durelli
Sites: University of Turin, Italy
Funding: Not available
Results/Publications: Not available
Last update: Spring 2001

Agent: Novantrone® (mitoxantrone for injection concentrate) and either Avonex® (Interferon beta-
1a) or Copaxone® (glatiramer acetate)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Novantrone 12 mg2 q 3 mo x 4 doses iv
Outcome parameters: Safety, scoring technique, MRI
Type of MS: RR, SP
Number of Subjects: 50
Start date: September 2001
Observation period: 12 months
Investigators: P. Calabresi, J. Cohen, F. Lublin, T. Vollmer
Sites: University of Maryland, College Park; Cleveland Clinic Foundation; Mount Sinai School of
Medicine, New York; Yale University, New Haven, CT
Funding: Investigator sponsored
Results/Publications: Not available
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate) and Betaseron® (Interferon beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Physician blinding
Dose/route: Novantrone 20 mg q mo iv methylprednisolone or methylprednisolone + Betaseron 250
mcg qod sc for 6 mo, then all Betaseron
Outcome parameters: Frequency of relapse, EDSS, MRI
Type of MS: RR
Number of Subjects: 220
Start date: January 1999
Observation period: 3 years
Investigators: G. Edan
Sites: Multicenter, France and Italy
Funding: French Health Ministry, Schering AG
Results/Publications: Not available
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate) and Betaseron® (Interferon beta-1b)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Novantrone 12 mg2 (1st mo) and 5 mg2 (2nd and 3rd mo and every 3rd mo) + Betaseron
Outcome parameters: MRI, relapse rates, EDSS
Type of MS: RR, SP
Number of Subjects: 10
Start date: Not available
Observation period: 6 months
Investigators: D. Jeffery, N. Chepuri, J. Rosenburg
Sites: Wake Forest University, Winston-Salem, NC
Funding: Berlex Laboratories, Inc., Immunex Corporation
Results/Publications: Well tolerated; clinical and MRI measures responded well; relapse rates
decreased by 74%; by last scan 2 pts had new enhancing lesions (Abstract #S23.004, AAN 2002)
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate) and ZINECARD® (dexrazoxane for
injection)
Mode of action/purpose of study: To affect immune function and protect cardiac function
Study description: Open label
Dose/route: Novantrone 12 mg2 + Dexrazoxane 600 mg2 q 3 mo
Outcome parameters: CBC, multigated radionuclide angiography, measure troponin-I (short-term
measure of cardiotoxicity)
Type of MS: SP, PR, worsening RR
Number of Subjects: 26
Start date: Not available
Observation period: 24 months
Investigators: D. Mikol, E. Bernitsas
Sites: University of Michigan, Ann Arbor
Funding: Immunex Corporation
Results/Publications: Favorable safety and tolerability profile, study ongoing (Abstract #P06.084,
AAN 2002)
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate) and methylprednisolone
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Induction therapy with Novantrone 20 mg iv + methylprednisolone 1 g iv, followed by
Novantrone, other long-term modifying therapy, or no maintenance therapy
Outcome parameters: Clinical, MRI, safety, EDSS
Type of MS: RR
Number of Subjects: 100
Start date: 1992
Observation period: 6 months
Investigators: E. Le Page, M. Coustans, G. Taurin, J. Chaperon, G. Edan
Sites: CHU de Rennes, France
Funding: Not available
Results/Publications: Clinical benefit and reduction of MRI activity with Novantrone induction
therapy (Abstract #P03.023, AAN 2002)
Last update: Spring 2002

Agent: Novantrone® (mitoxantrone for injection concentrate) and methylprednisolone
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Methylprednisone 500 mg iv q 5 d + Novantrone 10/mg/m2 on d 3; q 3 mo for 1 yr; q 6
mo
Outcome parameters: EDSS
Type of MS: SP, PP
Number of Subjects: 70
Start date: Not available
Observation period: Not available
Investigators: O. Schüler, M. Strupp, S. von Stuckrad-Barre, R. Hohlfeld, T. Brandt
Sites: Multiple, Germany
Funding: Not available
Results/Publications: Stabilization or improvement in more than 80% of patients; design and short
follow-up do not permit general recommendation (Abstract, 12th Meeting of European Neurological
Society)
Last update: Fall 2002

Agent: PAXCEED™ (micellar paclitaxel)
Mode of action/purpose of study: To affect immune function
Study description: Open label study
Dose/route: 50 mg2 q mo iv
Outcome parameters: EDSS, relapses, MRI
Type of MS: SP
Number of Subjects: 20
Start date: 1998
Observation period: 3 years
Investigators: P. O'Connor
Sites: St. Michael's Hospital, Toronto
Funding: Angiotech, Inc.
Results/Publications: Pending
Last update: Spring 2002

Agent: PAXCEED™ (micellar paclitaxel)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 50-75 mg2 q mo iv vs. PBO
Outcome parameters: MRI, clinical
Type of MS: SP
Number of Subjects: 60
Start date: 1999
Observation period: 9 months
Investigators: P. O'Connor
Sites: St. Michael's Hospital, Toronto, and others in Canada
Funding: Angiotech, Inc.
Results/Publications: Failed to meet statistical significance, discontinuing development for MS
(Angiotech press release, 2/25/02)
Last update: Spring 2002

Agent: Pixantrone (BBR 2778)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Four infusions, starting at 120 mg/m2 (dose escalation)
Outcome parameters: MRI, cardiac safety profile, safety, tolerability, and number of infusions
required to reduce white blood cell count
Type of MS: RR
Number of Subjects: 15-20
Start date: 2003
Observation period: Not available
Investigators: R. Gonsette
Sites: Belgium National Centre for Multiple Sclerosis, Melsbroek, Belgium
Funding: Novuspharma SpA
Results/Publications: Not available
Last update: Winter 2003

Agent: Provigil® (modafinil)
Mode of action/purpose of study: To improve fatigue
Study description: Single blinding, placebo control
Dose/route: PBO (wk 1-2), Provigil 200 mg/d (wk 3-4), Provigil 400 mg/d (wk 5-6), PBO (wk 7-9)
Outcome parameters: EDSS, FSS, MFIS, VAS-F
Type of MS: RR, PP, SP
Number of Subjects: 72
Start date: Not available
Observation period: 9 weeks
Investigators: K. Rammohan and others
Sites: Ohio State University, Columbus
Funding: Not available
Results/Publications: 200 mg/d significantly improves fatigue and is well tolerated (Journal of
Neurology, Neurosurgery and Psychiatry 2002;72:179-183)
Last update: Spring 2002

Agent: Provigil® (modafinil)
Mode of action/purpose of study: To improve fatigue after Avonex injection
Study description: Open label
Dose/route: 200 mg/d for 2 wk
Outcome parameters: Selective Reminding Test, verbal memory, FSS
Type of MS: RR
Number of Subjects: 22
Start date: November 2000
Observation period: 2 weeks
Investigators: L. Krupp
Sites: State University of New York, Stony Brook
Funding: Biogen, Inc., Cephalon, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as ETOMS study
Study description: Open label, longitudinal follow-up
Dose/route: 22 mcg/wk
Outcome parameters: Proportion with relapses, frequency of relapse, MRI
Type of MS: First clinical episode
Number of Subjects: 308
Start date: 1997
Observation period: 2 years
Investigators: Multiple
Sites: Multicenter, Europe
Funding: Serono, Inc.
Results/Publications: Treatment did not prevent MS, but significantly reduced the rate of
development of clinically definite MS, delayed conversion to definite MS, and reduced accumulation
of new MRI-detected lesions (The Lancet 2001 May 19;357(9268):1576-82; Multiple Sclerosis
2002;8(suppl 1):S8)
Last update: Winter 2003

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 22 mcg/wk sc
Outcome parameters: Time to progression, EDSS, RFSS, relapses
Type of MS: SP
Number of Subjects: 364
Start date: September 1995
Observation period: 3 years
Investigators: O. Anderson and others
Sites: Multicenter, Scandinavia
Funding: Serono, Inc.
Results/Publications: Study discontinued Fall 1999; no impact on disability or relapse rate (Multiple
Sclerosis 2001;S38:004)
Last update: Winter 2003

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Open label, labs blinded
Dose/route: 22 mcg/wk sc vs. 44 mcg/wk sc tiw
Outcome parameters: Liver/thyroid function, autoantibody serum level
Type of MS: RR
Number of Subjects: 250
Start date: June 1999
Observation period: 1 year
Investigators: L. Durelli and others
Sites: University of Turin, Italy and others
Funding: Serono, Inc.
Results/Publications: Not available
Last update: Spring 2001

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as SPECTRIMS study
Study description: Double blinding, placebo control
Dose/route: 22 mcg/wk sc vs. 44 mcg/wk sc vs. PBO
Outcome parameters: Progression of disability
Type of MS: SP
Number of Subjects: 618
Start date: 1994
Observation period: 6 years
Investigators: Multiple
Sites: Multicenter
Funding: Serono, Inc.
Results/Publications: No significant effect on disability progression; significant treatment benefit on
exacerbation-related outcomes and MRI, particularly in pts with relapses in 2 years pre-study
(Neurology 2001;56(11):1496-1513)
Last update: Spring 2002

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as PRISMS study
Study description: Placebo control, crossover
Dose/route: Rebif 44 mcg tiw sc vs. 22 mcg tiw sc
Outcome parameters: EDSS, MRI
Type of MS: RR
Number of Subjects: 560
Start date: 1994
Observation period: 6-7 years
Investigators: Multiple
Sites: Multicenter, Australia, Canada, Europe
Funding: Serono, Inc.
Results/Publications: Both doses effective for up to 4 years with evidence of dose response;
outcomes better for pts treated for 4 years than crossover groups (Neurology 2001;56:1628-1636)
Last update: Spring 2002

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function
Study description: Follow-up of subjects in PRISMS study
Dose/route: Rebif 44 mcg vs. 22 mcg tiw sc
Outcome parameters: Disability progression, frequency of relapse, MRI
Type of MS: RR
Number of Subjects: 558
Start date: October 2001
Observation period: Annual follow-up 2001-2003
Investigators: Multiple
Sites: Multicenter, Australia, Canada, Europe
Funding: Serono, Inc.
Results/Publications: Not available
Last update: Spring 2002

Agent: Rebif® (interferon beta-1a) vs. Avonex® (interferon beta-1a)
Mode of action/purpose of study: To affect immune function; also known as EVIDENCE study
Study description: Open label, physician blinding
Dose/route: Rebif 44 mcg tiw sc vs. Avonex 30 mcg/wk im
Outcome parameters: Proportion relapse-free, MRI
Type of MS: RR
Number of Subjects: 677
Start date: December 1999
Observation period: 24 wk, extension to 48 wk
Investigators: H. Panitch, P. Coyle, D. Goodin, B. Weinshenker, P. O'Connor, others
Sites: Multicenter, U.S., Canada, Europe
Funding: Serono, Inc.
Results/Publications: Rebif had significantly greater impact than Avonex on primary and secondary
outcomes investigated after 24 and 48 weeks of treatment (Abstracts #S13.005, S13.006, S67.004,
AAN 2002; Journal of the Neurological Sciences 2001;187:436; Multiple Sclerosis
2001;7(suppl):594; Neurology 2002; 59:1496-1506)
Last update: Winter 2003

Agent: Rebif® (interferon beta-1a)
Mode of action/purpose of study: To reduce injection side effects by using an auto-injector,
Rebiject™ Mini
Study description: Open label comparison
Dose/route: Rebif 44 mcg tiw sc, with Rebiject™ Mini, an auto-injector, or by manual injection
Outcome parameters: Injection site reactions
Type of MS: RR
Number of Subjects: 2116
Start date: October 2001
Observation period: Up to 3 months after last subject is enrolled
Investigators: Multiple
Sites: Multicenter, U.S.
Funding: Serono, Inc.
Results/Publications: Not available
Last update: Spring 2002

42
Agent: Rehabilitation
Mode of action/purpose of study: To improve symptoms following acute relapses
Study description: Physician blinding
Dose/route: Intensive outpatient rehabilitation
Outcome parameters: ISS, SF-36, other scales
Type of MS: RR, SP
Number of Subjects: 160
Start date: February 2000
Observation period: 12 months
Investigators: R. Kinkel, F. Bethoux, D. Miller
Sites: Cleveland Clinic Foundation
Funding: National MS Society
Results/Publications: Not available
Last update: Spring 2001

Agent: Rilutek® (riluzole)
Mode of action/purpose of study: To enhance nerve function
Study description: Open label
Dose/route: 50 mg/d po x 2
Outcome parameters: MRI (spinal cord atrophy, T1 black holes), EDSS
Type of MS: PP
Number of Subjects: 16
Start date: 1997
Observation period: 2 years
Investigators: C. Polman, F. Barkhof, N. Kalkers
Sites: Free University Medical Centre, Amsterdam
Funding: Internal funds
Results/Publications: No significant effects; trend toward reduced progression of MRI parameters
(Multiple Sclerosis, in press)
Last update: Spring 2001

Agent: Rituxan® (rituximab)
Mode of action/purpose of study: To affect immune function
Study description: Open label, neuroradiologist blinding
Dose/route: 4 doses of Rituxan/wk x 4, iv
Outcome parameters: MRI
Type of MS: RR
Number of Subjects: 30
Start date: March 2002
Observation period: 1 year
Investigators: A. Cross
Sites: Washington University, St. Louis
Funding: National MS Society
Results/Publications: Not available
Last update: Spring 2002

43
Agent: Roferon® (interferon alpha-2a)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 6 mg po vs.18 mg po vs. PBO
Outcome parameters: Gd-MRI
Type of MS: RR
Number of Subjects: 30
Start date: September 1997
Observation period: 9 months
Investigators: S. Brod
Sites: University of Texas Health Sciences Center, Houston
Funding: NIH
Results/Publications: No significant effect on enhancing lesion; post hoc analysis showed possible
treatment effect in 10,000 IU group (Neurology 2001;57:845-852)
Last update: Spring 2002

Agent: Rolipram (phosphodiesterase-4 inhibitor)
Mode of action/purpose of study: To affect immune function
Study description: Open label, crossover
Dose/route: 3 mg tid po
Outcome parameters: Frequency of relapse, scoring technique, MRI
Type of MS: RR, SP
Number of Subjects: 18
Start date: January 2002
Observation period: 14 months
Investigators: R. Martin
Sites: NIH, Bethesda, MD
Funding: NIH
Results/Publications: Not available
Last update: Spring 2002

Agent: SAIK-MS (laqunimod, ABR-215062)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control, randomized
Dose/route: 0.1 mg/d po vs. 0.3 mg/d po vs. PBO
Outcome parameters: MRI, EDSS, MSFC
Type of MS: Relapsing
Number of Subjects: 180
Start date: April 2002
Observation period: 18 months
Investigators: C. Polman and others
Sites: VU Medical Centre, Amsterdam, and 20 others, The Netherlands, Sweden, United Kingdom,
Russia
Funding: Active Biotech AB
Results/Publications: Not available
Last update: Fall 2002

44
Agent: Schwann cell transplantation
Mode of action/purpose of study: To affect immune function
Study description: Placebo control
Dose/route: Intracranial transplant of schwann cells as remylination therapy vs. sham injection
Outcome parameters: MRI correlates, biopsy to determine remyelination, clinical parameters,
VERs, safety
Type of MS: SP
Number of Subjects: 5
Start date: July 2001
Observation period: 3 years
Investigators: T. Vollmer, J. Kocsis, S. Waxman, D. Spencer, J. Gore
Sites: Yale School of Medicine, New Haven, CT
Funding: The Myelin Project
Results/Publications: 2 pts have undergone procedure (Yale University news release, March 14,
2002)
Last update: Spring 2002

Agent: T cell receptor peptide (V beta 5.25.3; ATM-027)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1 mg/kg iv, 2 mg/kg iv or 5 mg/kg iv, depending on levels of Vb 5.25.3 T cells
Outcome parameters: Immune function, MRI, CSF
Type of MS: RR
Number of Subjects: 50
Start date: August 1998
Observation period: 16 months
Investigators: L. Blumhardt and others
Sites: University of Nottingham, UK
Funding: Astra Arcus
Results/Publications: Consistent suppression of targeted T cells achieved, but effect size on MRI
considerably less than targeted amount (Annals of Neurology 2002 Apr;51(4):467-74)
Last update: Spring 2002

Agent: T cell receptor peptide (CDR2 BV6S26S5)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: 300 mcg
Outcome parameters: Safety and immunogenicity
Type of MS: Not available
Number of Subjects: 10
Start date: Not available
Observation period: 48 weeks
Investigators: E. Morgan and others
Sites: The Immune Response Corporation, Carlsbad, CA; Sharp Rees-Stealy, San Diego, CA
Funding: The Immune Response Corporation
Results/Publications: Safe and immunogenic (Journal of Neuroscience Research 2001;64:298-301)
Last update: Spring 2002

45
Agent: T cell vaccination
Mode of action/purpose of study: To affect immune function
Study description: Partial blinding
Dose/route: 1.0 ml IR902 (peptides with IFA) im, 1.0 ml IFA (PBO) im or 0.1 ml IR903 (peptides in
saline) id
Outcome parameters: EDSS, MSFC
Type of MS: RR, SP
Number of Subjects: 60
Start date: August 2000
Observation period: 6 months
Investigators: J. Bowen
Sites: University of Washington, Seattle
Funding: The Immune Response Corporation
Results/Publications: Terminated prematurely
Last update: Fall 2002

Agent: T cell vaccination
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: Multiple doses sc
Outcome parameters: Duration of attack, frequence of relapse, EDSS, MRI
Type of MS: RR
Number of Subjects: 18
Start date: March 2002
Observation period: 24 months
Investigators: J. Zhang, J. Killian, V. Rivera
Sites: Baylor College of Medicine, Houston
Funding: Private funding
Results/Publications: Not available (Critical Reviews of Immunology 2001;21:41-55; Journal of
Neurology, in press)
Last update: Spring 2002

Agent: T cell vaccination
Mode of action/purpose of study: To affect immune function
Study description: Double blinding
Dose/route: 4 ml vaccine sc
Outcome parameters: EDSS, MSFC, MRI
Type of MS: RR
Number of Subjects: 30
Start date: Spring 2002
Observation period: 1 year
Investigators: D. Karussis, R. Abulaix, O. Abramsky
Sites: Hadassah Hospital, Jerusalem, Israel
Funding: Grant for TCV
Results/Publications: Not available
Last update: Spring 2002

46
Agent: T cell vaccination
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 50 x 10 million myelin-specific attenuated T cells derived from CSF, x 3 sc
Outcome parameters: MRI, bimonthly
Type of MS: RR
Number of Subjects: 60
Start date: September 2000
Observation period: 18 months
Investigators: R. Medaer, R. Stinissen, J. Raus
Sites: Dr. Willems-Instituut, Diepenbeek, Belgium
Funding: Flemish Government
Results/Publications: Not available
Last update: Spring 2000

Agent: T cell vaccination against whole bovine myelin
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 40 million lymphocytes (1 ml) sc x 11
Outcome parameters: Brain MRI, EDSS, immune parameters
Type of MS: SP
Number of Subjects: 80
Start date: September 1999
Observation period: 3 years
Investigators: L. Weiner
Sites: University of Southern California, Los Angeles
Funding: National MS Society, NIH
Results/Publications: Not available
Last update: Spring 2000

Agent: Teriflunomide
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Teriflunomide 7 mg po vs. 14 mg po vs. PBO po
Outcome parameters: MRI, EDSS, relapses
Type of MS: RR
Number of Subjects: 180
Start date: 2000
Observation period: 9 months
Investigators: P. O'Connor
Sites: Multicenter, Canada
Funding: Aventis Pharmaceuticals
Results/Publications: Not available
Last update: Spring 2002

47
Agent: Tetrahydrocannabinol (marijuana)
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding, placebo control, crossover
Dose/route: 10 mg/d po tetrahydrocannabinol
Outcome parameters: Electronic scoring of ataxia and EMG scoring of spasticity
Type of MS: RR, SP
Number of Subjects: 40
Start date: December 2001
Observation period: 2 x 4 weeks
Investigators: P. Sorensen
Sites: Rigshospitalet, Copenhagen, Denmark
Funding: IPC
Results/Publications: Not available
Last update: Spring 2002

Agent: Valtrex® (valacyclovir)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1000 mg po tid
Outcome parameters: Serial MRI, neuro deficit, number of attacks, time of first attack
Type of MS: RR
Number of Subjects: 70
Start date: July 1996
Observation period: 32 weeks
Investigators: H. J. Hansen, O. Anderson, others
Sites: University Hospital, Aarhus, Denmark; Salgrenska Hospital, Gothenburg, Sweden
Funding: Danish MS Society, GlaxoSmithKline
Results/Publications: No effect on MS lesion formation or clinical activity; subset of patients with
>1 active lesion at baseline (n=17) showed fewer active lesions on Valtrex (Abstract #S11.001, AAN
2001; Neurology 2002;58:31-36)
Last update: Spring 2002

Agent: Valtrex® (valacyclovir)
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: 1000 mg bid po
Outcome parameters: EDSS, FS, MRI, number of attacks, time to failure (prolonged decline in
EDSS or FS)
Type of MS: RR, CP
Number of Subjects: 59
Start date: July 1997
Observation period: 2 years
Investigators: J. Friedman, C. Plank, J. Zabriskie
Sites: Rockefeller University, New York
Funding: GlaxoSmithKline
Results/Publications: Safe and well tolerated, increases in rbc indices in 13 treated pts; one pt
developed mild, reversible anemia (Abstract #P05.097, AAN 2001)
Last update: Spring 2002

48
Agent: Viagra® (sildenafil citrate)
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding and placebo control (16 weeks); open label (up to 48 weeks)
Dose/route: po
Outcome parameters: International Index of Erectile Function Questionnaire
Type of MS: Male, stable for 1 yr or more, erectile dysfunction Number of Subjects: 250
Start date: February 1998
Observation period: Up to 64 wk
Investigators: R. Schapiro and others
Sites: Multicenter, International
Funding: Pfizer Inc.
Results/Publications: Efficacy in patients with ED and MS sustained over periods ranging from 24-
48 wk (Abstract #P06.087, AAN 2002)
Last update: Spring 2002

Agent: Viagra® (sildenafil citrate)
Mode of action/purpose of study: To improve symptoms
Study description: Double blinding, placebo control
Dose/route: 50 mg or 100 mg po
Outcome parameters: Multiple sexual function assays
Type of MS: RR, SP, female
Number of Subjects: Not available
Start date: March 1999
Observation period: 4 months
Investigators: E. Frohman, S. Litwiller
Sites: University of Texas Southwestern Medical Center, Dallas
Funding: Yellow Rose Foundation
Results/Publications: Not available
Last update: Spring 2000

Agent: WA-J695
Mode of action/purpose of study: To affect immune function
Study description: Double blinding, placebo control
Dose/route: Not available
Outcome parameters: Not available
Type of MS: Clinically definite MS
Number of Subjects: 6
Start date: Not available
Observation period: Not available
Investigators: Not available
Sites: Mount Sinai School of Medicine, New York
Funding: Wyeth-Ayerst
Results/Publications: Terminated prematurely
Last update: Winter 2003

49
Agent: Zenapax® (daclizumab)
Mode of action/purpose of study: To affect immune function
Study description: Open label, crossover
Dose/route: 1 mg/kg/mo iv
Outcome parameters: Frequency of relapse, scoring technique, MRI
Type of MS: RR, SP
Number of Subjects: 10
Start date: February 2000
Observation period: 15.5 months
Investigators: R. Martin
Sites: NIH, Bethesda, MD
Funding: NIH
Results/Publications: Tolerated well, safe, leads to 75% reduction in inflammatory activity by MRI
in majority of patients (Abstract 320, FOCIS 2nd Annual Meeting 2002)
Last update: Fall 2002

Agent: Zocor® (simvastatin)
Mode of action/purpose of study: To affect immune function
Study description: Open label
Dose/route: daily, po
Outcome parameters: Mean # gd-enhancing lesions pretreatment vs. post-treatment, other MRI
parameters, MSFC, rate and severity of relapses
Type of MS: RR
Number of Subjects: 32
Start date: March 2001
Observation period: 9 months
Investigators: L. Key, I. Singh, W. Tyor
Sites: Medical University of South Carolina, Charleston; Yale University, New Haven, CT;
University of Colorado Health Sciences Center, Denver
Funding: Merck & Co., Inc.
Results/Publications: Not available
Last update: Spring 2002

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