
An exploratory, randomized, controlled trial
http://www.neurology.org/cgi/content/abstract/60/1/44
Neurology 2003;60:44-51
S.M. Leary, MRCP, D.H. Miller, FRCP, V.L. Stevenson, MRCP, P.A. Brex,
MRCP, D.T. Chard, MRCP and A.J. Thompson, FRCP
From the NMR Research Unit, Institute of Neurology, University College
London, UK.
Background:
Patients with primary progressive MS have atypical clinical and MRI characteristics and have been excluded from most therapeutic trials. The authors report a randomized, controlled trial restricted to primary progressive MS.
Methods:
Fifty subjects were randomized to weekly IM interferon ß-1a 30 µg, 60 µg, or placebo for 2 years. The primary endpoint was time to sustained progression in disability. Secondary outcomes included the timed 10-meter walk, nine-hole peg test, and on MRI, T2 and T1 brain lesion loads and brain and spinal cord atrophy.
Results:
The 30-µg dose of interferon ß-1a was well tolerated, but the 60-µg dose caused severe flulike reactions and raised liver enzymes. No treatment effect was seen on the primary endpoint. Subjects on interferon ß-1a 30 µg had a lower rate of accumulation of T2 lesion load than controls (p = 0.025); subjects on 60 µg had a greater rate of ventricular enlargement than controls (p = 0.025).
Conclusions:
This study has demonstrated that interferon ß-1a 30 µg was well tolerated, identified useful outcome measures, but showed no efficacy on the primary outcome measure or on most of the secondary outcome measures.
© 2003 American Academy of Neurology