drugset / Trial / NCT02208050

A Study of the Effectiveness of Fampridine in Improving Upper Limb Function in MS

NCT02208050

Phase 4 Completed 64 enrolled University College Dublin
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to examine the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). Fampridine has been shown to be effective in improving motor function, specifically walking ability in prior studies in this patient population and is currently licensed for this use in Europe and the United States. Upper limb dysfunction is common in SPMS and PPMS and often underestimated. Fampridine effects action potential conduction in demyelinated nerve fibres and we would hypothesise that the improvement previously reported in walking ability would be similar to that on upper limb dysfunction. Our study aims to address this question using both independent and patient reported outcomes in the context of a randomised placebo controlled crossover trial.

Timeline

Start
2014-02-21
Primary completion
2016-02-16
Completion
2016-02-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalfampridine Small molecule 10 mg Oral