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

NCT02146534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-03-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

extended release fampridine

pts will receive Fampyra 10 mg BID PO for the duration of the study

DRUG

Placebo

placebo will be taken PO BID

Sponsors & Collaborators

  • CogState Ltd.

    collaborator INDUSTRY

  • Clinique Neuro-Outaouais

    lead OTHER

Principal Investigators

  • Francois H Jacques, MD FRCP · Clinique Neuro-Outaouais

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02146534 on ClinicalTrials.gov