Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks (total of 18 sessions).

Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as per label, and the other half will receive a placebo BID.

All patients will continue to take their medication (fampridine or placebo) during a subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and 14 weeks.

Study Objectives:

Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of incidence of responders, degree of response, and duration of response.

Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of quality of life measures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Neuro-Outaouais
• Collaborators: Clinique NeuroGym; CogState Ltd.
• Treatments: 4-Aminopyridine

Criteria

Inclusion Criteria:

• Diagnosis of McDonald criteria MS of all types and of age 18 and older.

• Subjects who meet the prescribing criteria for Fampyra as per product monograph.

• Therapeutic stability (MS and symptomatic treatment) for 3 months prior to screening and for the duration of the study.

• Pyramidal system functional assessment score of 2 or greater and the ability to complete all the assessments with or without aids.

• Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

• Any contraindication to receiving fampridine as per product monograph including but not limited to prior history of epilepsy, renal dysfunction (abnormal serum creatinine), concomitant treatment with cimetidine or quinidine.

• Ongoing treatment with fampridine or prior history of fampridine intolerance or ineffectiveness

• Any other condition that would preclude them from undergoing the NeuroGym training.