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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,neuropsycological(NPT),ambulation index(AI),and Expanded Disability Status Score(EDSS)score.Paresthesias and abdominal pain were common and were dose limiting in eight patients.Three patient 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. |
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adverse drug reaction
confusion
diaminopyridine,3,4
multiple sclerosis
multiple sclerosis,treatment of
pain,abdominal
paresthesias
treatment of neurologic disorder
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