Status:
COMPLETED
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 walkin...
Detailed Description
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-ou...
Eligibility Criteria
Inclusion
- Clinically definite MS (according to McDonald criteria),
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT00811902
Start Date
December 1 2008
End Date
March 1 2010
Last Update
February 26 2016
Active Locations (7)
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1
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-aventis Administrative Office
Laval, Canada
3
Sanofi-aventis Administrative Office
Helsinki, Finland
4
Sanofi-Aventis Administrative Office
Paris, France