Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.A cross-over, double-blinded, placebo-controlled study.

Phase 1

• Conditions: Multiple Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-005076-34-BE
• Lead Sponsor: Cliniques Universitaires Saint-Luc, Neurologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-14
• Study Completion: 2015-09-29
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria:
1.aged > 18 years and < 65 years
2.diagnosed with clinically definite MS (RR, SP or PP form)
3.have an EDSS score = 6.0
4.present a subjective complaint of impaired walking ability.

After 4 weeks of treatment, patients who respond to treatment with Fampridine (clinical response is based on improvement of walking ability and self assessed walking capacity) will be randomized into one of the groups (active drug or placebo)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria are met at the screening visit or at any time during the screening period:
1.Presence of gait or walking disability not attributed to MS
2.EDSS score > 6.0
3.Relapse or steroid treatment within the last 4 weeks before inclusion
4.Any history of seizure, epilepsy or other convulsive disorder with the exception of febrile seizures in childhood.
5.Mild, moderate or severe renal impairment
6.Contraindication to Motor Evoked Potentials
7.Incapacity to walk on a treadmill at a comfortable speed during at least 3 minutes
8.Concurrent treatment with other medicinal products containing 4-aminopyridine
9.Concomitant use of medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
10.Breastfeeding or pregnant female subjects or subjects who are considering becoming pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified