Prolonged-release oral Fampridine in Multiple Sclerosis: effects on clinical, neurophysiological and quantified gait analysis parameters.

INTERVENTION: Trade Name: Fampyra Product Name: Fampridine Product Code: BIIB041 Pharmaceutical Form: Prolonged‐release tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Multiple Sclerosis Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The primary objective of the study is to assess the effect of treatment with prolonged‐release fampridine 10 mg twice, on the quantified gait analysis parameters (kinematics, dynamics, mechanical work). Primary end point(s): Change from baseline in the quantified gait analysis kinematic, dynamic and mechanical work parameters Secondary Objective: The secondary objectives of this study are the followings:; ‐quantified gait analysis by electromyographic activity and energy cost; ‐clinical efficacy on strength, spasticity, walking tests, subjective self assessed walking functional parameters, quality of life, and fatigue; ‐amplitude and latency of motor evoked potentials Timepoint(s) of evaluation of this end point: Each patient will be randomized, after inclusion, in group 1 or 2. Group 1 will receive the treatment during 6 weeks, then have a period of 2 weeks of wash‐out, and after this be treated with placebo for 6 weeks.; Group 2 will receive the placebo first for 6 weeks, be washed‐out for 2 weeks, and then have the IMP for 6 weeks.; ; Each patient will thus be evaluated 4 times, before and at the end of each period of treatment. SECONDARY OUTCOME: Secondary end point(s): ‐comparison of change after treatment, of quantified parameters of electromyography and energy cost an gait analysis ; ‐comparison of clinical parameters (spasticity, strength, muscular stiffness, walking tests) and subjectives scores (MSWS‐12, Borg scale, quality of life, fatigue); ‐comparison of motor evoked potentials parameters Timepoint(s) of evaluation of this end point: Each patient will thus be evaluated 4 times, before and at the end of each period of treatment.; These evaluations will be coupled with the primary endpoint evaluations. 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