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

January 28, 2016 updated by: Sanofi

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Laval, Canada
        • Sanofi-Aventis Administrative Office
  • Finland
      • Helsinki, Finland
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Germany
      • Berlin, Germany
        • Sanofi-Aventis Administrative Office
  • Norway
      • Lysaker, Norway
        • Sanofi-Aventis Administrative Office
  • Spain
      • Barcelona, Spain
        • Sanofi-Aventis Administrative Office
  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nerispirdine 50mg
Nerispirdine 50mg once daily for 14 weeks
Drug: Nerispirdine
tablet, oral administration
Other Names:
  • HP184
Experimental: Nerispirdine 100mg
Nerispirdine 100mg once daily for 14 weeks
Drug: Nerispirdine
tablet, oral administration
Other Names:
  • HP184
Experimental: Nerispirdine 200mg
Nerispirdine 200mg once daily for 14 weeks
Drug: Nerispirdine
tablet, oral administration
Other Names:
  • HP184
Placebo Comparator: Placebo
Placebo for Nerispirdine once daily for 14 weeks
Drug: placebo
tablet, oral administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
Time Frame: 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 18, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRI10566
  • 2008-001999-67 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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