FAME - Fampyra outcome measures study: a study of responsiveness of different outcome measures to Fampyra treatment.

INTERVENTION: Trade Name: Fampyra Product Name: Fampyra Pharmaceutical Form: Tablet INN or Proposed INN: FAMPRIDINE CAS Number: 504‐24‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ 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 aim of the trial is to compose a multiple outcome measure trial to; 1. evaluate the relative sensitivity of a comprehensive series of clinical tests for the identification of multiple sclerosis patients that respond to Fampyra; 2. compare the effect size of Fampyra treatment when assessed by the Six Spot Step Test Primary end point(s): The mean change in six spot step test from day 0 to 28. Secondary Objective: Timepoint(s) of evaluation of this end point: 9 weeks SECONDARY OUTCOME: Secondary end point(s): Mean changes in Timed 25 Foot Walk, Hip Flexion Dynamometry, Knee Extension Dynamometry, Chair Rise Test, 9 Hole Peg Test and Symbol Digit Modalities Test. Timepoint(s) of evaluation of this end point: 9 weeks INCLUSION CRITERIA: Patients with clinically definite multiple sclerosis diagnosed according to the McDonald criteria, aged 18‐60 years, EDSS 4‐7, pyramidal FS >= 2, able to transport self to University of Southern Denmark in Odense. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range