A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine on upper limb impairment in Multiple Sclerosis

Phase 4

• Conditions: Multiple Sclerosis; Neurological - Multiple sclerosis

• Registration Number: ACTRN12613000331730
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Multiple sclerosis; impaired upper limb function (NB this applies to the group of 40 patients; there will also be 20 healthy controls who are being included primarily for validation of electrophysiological measurements as there are no published normal values for these parameters.

Exclusion Criteria

Age < 18 years; history of seizures or epilepsy; hypersensitivity to fampridine; moderate/severe renal impairment; pregnancy; current or recent (60 days) MS relapse; alternative likely cause for upper limb impairment (e.g. peripheral neuropathy, injury); current or recent (60 days) therapy with corticosteroids; current therapy with benzodiazepines; recent (within 60 days) addition of new therapy for multiple sclerosis including disease-modifying therapies and symptomatic therapies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper limb function using time to complete 9-hole peg test[Baseline, 2, 4, 8 weeks and 1 month after completion of treatment]

Secondary Outcome Measures

Name	Time	Method
Sensory discrimination capacity using standard indices of texture discrimination (Fabric Matching Test), limb position sense (Wrist Position Sense Test) and tactile object recognition (functional Tactile Object Recognition Test). [Baseline, 2, 4 and 8 weeks and 1 month after completion of treatment];Central motor conduction time measured using transcranial magnetic motor evoked potentials[Baseline, 4, 8 weeks and 1 month after completion of treatment];Cortical excitability measured using transcranial magnetic stimulation[Baseline, 4, 8 weeks and 1 month after completion of treatment];Pattern-shift visual evoked potential latency of the p100 (measured using Synergy electromyography machine)[Baseline, 4, 8 weeks and 1 month after completion of treatment];Upper extremity muscle strength measured using neurological examination (MRC scale of muscle power) and grip strength measured using a hand-held dynamometer[Baseline, 2, 4 and 8 weeks and 1 month after completion of treatment]