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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nerispirdine

placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-aventis Administrative Office
Sanofi-aventis Administrative Office
Sanofi-aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Nerispirdine 50mg

Nerispirdine 100mg

Nerispirdine 200mg

Placebo

Arm Description

Nerispirdine 50mg once daily for 14 weeks

Nerispirdine 100mg once daily for 14 weeks

Nerispirdine 200mg once daily for 14 weeks

Placebo for Nerispirdine once daily for 14 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)

Full Information

NCT ID

NCT00811902

First Posted

December 18, 2008

Last Updated

January 28, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00811902

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

405 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nerispirdine 50mg

Arm Type

Experimental

Arm Description

Nerispirdine 50mg once daily for 14 weeks

Arm Title

Nerispirdine 100mg

Arm Type

Experimental

Arm Description

Nerispirdine 100mg once daily for 14 weeks

Arm Title

Nerispirdine 200mg

Arm Type

Experimental

Arm Description

Nerispirdine 200mg once daily for 14 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for Nerispirdine once daily for 14 weeks

Intervention Type

Drug

Intervention Name(s)

Nerispirdine

Other Intervention Name(s)

HP184

Intervention Description

tablet, oral administration

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

tablet, oral administration

Primary Outcome Measure Information:

Title

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

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-aventis Administrative Office

City

Laval

Country

Canada

Facility Name

Sanofi-aventis Administrative Office

City

Helsinki

Country

Finland

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-aventis Administrative Office

City

Berlin

Country

Germany

Facility Name

Sanofi-Aventis Administrative Office

City

Lysaker

Country

Norway

Facility Name

Sanofi-aventis Administrative Office

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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