Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
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.