The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).
Secondary objectives:
To assess other measures of walking ability, tiredness, and lower limb muscular strength, spasticity, clinical assessment by subject and clinical assessment of change by the Study Investigator To assess the safety and tolerance of nerispirdine To evaluate the pharmacokinetics (PK) parameters of nerispirdine
Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period
Clinically definite MS (according to McDonald criteria),
Exclusion Criteria:
Multiple sclerosis exacerbation or clinical relapse within 6-month prior to the screening visit. Subject who is not able to complete two trials of a timed 25 foot walk, with or without an assisted device, Patients without valid V1, V2, and V4 T25-FW measurements are not eligible for randomization. Female patients who are either pregnant or breastfeeding.
Other protocol-defined inclusion/exclusion criteria may apply.
