Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion Criteria:

• 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.