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

Multiple Sclerosis Clinical Trial

Official title:

A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Nerispirdine 50 mg, 100 mg, and 200 mg in Patients With Multiple Sclerosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811902
• Other study ID #: DRI10566
• Secondary ID: 2008-001999-67
• Status: Completed
• Phase: Phase 2
• First received: December 18, 2008
• Last updated: January 28, 2016
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Nerispirdine
tablet, oral administration
• placebo
tablet, oral administration

Locations

Country	Name	City	State
Canada	Sanofi-aventis Administrative Office	Laval
Finland	Sanofi-aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-aventis Administrative Office	Berlin
Norway	Sanofi-Aventis Administrative Office	Lysaker
Spain	Sanofi-aventis Administrative Office	Barcelona
United States	Sanofi-aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Germany,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)		14 weeks	No
Secondary	Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)		14 weeks	No