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

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID: NCT00811902
Run by: Sanofi
People needed: 405
Starts: 2008-12-01
Expected to finish: 2010-03-01
Last updated by the study team: 2016-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Clinically definite MS (according to McDonald criteria),

You may not qualify if…

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.

Where it is running

Sanofi-aventis Administrative Office — Bridgewater, New Jersey, United States
Sanofi-aventis Administrative Office — Laval, Canada
Sanofi-aventis Administrative Office — Helsinki, Finland
Sanofi-Aventis Administrative Office — Paris, France
Sanofi-aventis Administrative Office — Berlin, Germany
Sanofi-Aventis Administrative Office — Lysaker, Norway
Sanofi-aventis Administrative Office — Barcelona, Spain

Full record on ClinicalTrials.gov

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