Multiple Sclerosis Clinical Trial

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

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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

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Full 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

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Eligibility 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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

405

Study ID:

NCT00811902

Recruitment Status:

Completed

Sponsor:

Sanofi

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There is 1 Location for this study

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Sanofi-aventis Administrative Office
Bridgewater New Jersey, 08807, 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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

405

Study ID:

NCT00811902

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

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