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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: placebo; Drug: Nerispirdine

• Registration Number: NCT00811902
• Lead Sponsor: Sanofi

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 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

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-out (follow-up) period

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Study First Posted: 2008-12-19
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-01
• Disposition First Submitted: 2016-01-28
• Disposition First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Disposition First Posted: 2016-02-26
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo for Nerispirdine once daily for 14 weeks
Nerispirdine 50mg	Nerispirdine	Nerispirdine 50mg once daily for 14 weeks
Nerispirdine 100mg	Nerispirdine	Nerispirdine 100mg once daily for 14 weeks
Nerispirdine 200mg	Nerispirdine	Nerispirdine 200mg once daily for 14 weeks

Primary Outcome Measures

Name	Time	Method
Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)	14 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)	14 weeks

Trial Locations

Locations (2)

Sanofi-Aventis Administrative Office; 🇳🇴 Lysaker, Norway

Sanofi-aventis Administrative Office; 🇪🇸 Barcelona, Spain