1 MAY 2000 AT 21:00 ET US
Contact: Communications Office
American Academy of Neurology
Multiple sclerosis patients finally have a more effective and safe weapon against fatigue, one of the most impairing and disabling symptoms of the disease, according to research presented during the American Academy of Neurology's 52nd Annual Meeting in San Diego, CA, April 29 -- May 6, 2000.
"Fatigue, a common symptom of multiple sclerosis, can be so disabling that it may impair one's ability to work at a time when there is minimal physical disability," said Kottil Rammohan, MD, a neurologist at Ohio State University in Columbus, OH, and lead author of the study. "Drugs presently used to treat fatigue are only marginally effective. Many of the patients who participated in this study had tried conventional fatigue treatments without benefit, but they responded to modafinil."
Modafinil is currently approved for the treatment of narcolepsy, a disorder of excessive daytime sleepiness. As the first non-addicting drug effective in reducing sleepiness and improving alertness, modafinil offers patients a favorable alternative to commonly prescribed stimulants that can cause serious long-term effects and have potential for abuse.
The nine-week study included 72 patients from two medical centers -- Ohio State University and Kaiser Permanente in San Diego, CA. All patients received placebo (inactive pill) for the first two weeks, 200 mg of modafinil for weeks three and four, 400 mg during weeks five and six, and placebo again for weeks seven, eight and nine.
"Over 85 percent of the patients were able to identify the drug from placebo based entirely on use and improvement of fatigue," said Rammohan. "This, in addition to the fact that modafinil changed patients' Fatigue Severity Scale scores in a favorable manner, would suggest that this drug may well become the first-line treatment against fatigue for multiple sclerosis patients."
Patients experienced few side effects, although headache and nervousness were reported more frequently during the 400 mg dose. Only four patients discontinued the study due to problems related to modafinil.
"Some patients found the 400 mg dosage more effective; however, most patients found the 400 mg to be too much," said Rammohan. "Generally the 200 mg of modafinil was very well tolerated by patients. Modafinil has no major toxicity and has a favorable long-term use record in Europe." The study was funded by a grant from Cephalon, Inc., which manufactures modafinil.
The American Academy of Neurology, an association of more than 16,500 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.
For more information about the American Academy of Neurology, visit its Web site at http://www.aan.com. For online neurological health and wellness information, visit NeuroVista at http://www.aan.com/neurovista.
EDITOR'S NOTE: Dr. Rammohan will present the research at the American
Academy of Neurology's 52nd Annual Meeting in San Diego, CA, during a platform
presentation on Monday, May 1, 2000, at 4:30 pm in Room 15A of the San
Diego Convention Center.