At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of clinically definite SPMS or PPMS
- ✓Age 18-70 years
- ✓EDSS score 4.0-7.0 inclusive
- ✓Evidence of significant upper limb dysfunction (9HPT 15-90 seconds on either hand)
- ✕History of epilepsy or previous seizures (including provoked)
- ✕AST or ALT ≥3× upper limit of normal
- ✕Clinically significant ECG findings, particularly cardiac conduction defects
- ✕Renal impairment: creatinine clearance <80 mL/min (by 24-hour urine or Cockcroft-Gault)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV Double Blind, Randomized, Placebo Controlled, Crossover Study of the Effectiveness of Oral Fampridine in Improving Upper Limb Function in Progressive Multiple Sclerosis
In Brief
A Phase 4 clinical trial evaluating Fampridine and Placebo for Secondary Progressive Multiple Sclerosis and Primary Progressive Multiple Sclerosis. Completed, enrolled 64 participants across 2 sites.
Detailed 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.