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Treatment with oral 3,4 diaminopyridine improves leg strength in multiple sclerosis patients

Results of a randomized, double-blind, placebo-controlled, crossover trial

From the Departments of Neurology (Drs. Bever, Panitch, Dhib-Jalbut, Khan, and Milo, K. Conway, E. Katz, and Dr. Johnson), Physical Therapy (Dr. Anderson), and Epidemiology and Preventive Medicine (Dr. Hebel), School of Medicine, and the Department of Pharmaceutical Sciences (Dr. Leslie), School of Pharmacy, University of Maryland; and the Research and Neurology Services (Drs. Bever, Panitch, Dhib-Jalbut, and Khan), VA Medical Center, Baltimore, MD.
Supported by grants RG 2127-A-1 and RG 2127-B-2 from the National Multiple Sclerosis Society.
Received February 22, 1996. Accepted in final form April 23, 1996.
Address correspondence and reprint requests to Dr. Christopher T. Bever, Jr., Department of Neurology, UMH, Room N4W46, 22 South Greene St., Baltimore, MD 21201.

To examine the efficacy and toxicity of oral 3,4 diaminopyridine (DAP) in dosages up to 100 mg/day, 36 patients with multiple sclerosis (MS) enrolled in a randomized, double-blind, placebo-controlled, crossover trial. The primary outcome measure was improvement of a prospectively defined neurologic deficit, which was leg weakness in 34 patients. Secondary outcome measures included the patient's subjective response, scored manual motor testing (MMT) of leg strength, scored leg strength from videotaped motor testing (VMT), quadriceps and hamstrings strength (QMT) measured by isometric dynamometry, neuropsychological testing (NPT), ambulation index (AI), and Expanded Disability Status Scale (EDSS) score. Paresthesias and abdominal pain were common and were dose limiting in eight patients. Three patients had episodes of confusion, and one patient had a seizure while on DAP. Eight patients withdrew from the study, leaving 28 evaluable patients for the efficacy analysis. The prospectively defined neurologic deficit improved in 24 patients-22 on DAP and 2 on placebo (p = 0.0005). All improvements were in leg weakness. Subjective response and measures of leg strength and function (MMT, VMT, QMT, and AI) improved on DAP compared with placebo. Neither NPT nor EDSS scores improved. DAP treatment can induce improvements in leg strength in MS patients, but toxicity is limiting in many patients.

NEUROLOGY 1996;47: 1457-1462

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