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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00811902
Recruitment Status : Completed
First Posted : December 19, 2008
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Nerispirdine Drug: placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nerispirdine 50mg
Nerispirdine 50mg once daily for 14 weeks
 Drug: Nerispirdine
tablet, oral administration
Other Name: HP184
Experimental: Nerispirdine 100mg
Nerispirdine 100mg once daily for 14 weeks
 Drug: Nerispirdine
tablet, oral administration
Other Name: HP184
Experimental: Nerispirdine 200mg
Nerispirdine 200mg once daily for 14 weeks
 Drug: Nerispirdine
tablet, oral administration
Other Name: HP184
Placebo Comparator: Placebo
Placebo for Nerispirdine once daily for 14 weeks
 Drug: placebo
tablet, oral administration


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) [ Time Frame: 14 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811902


Locations
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United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-aventis Administrative Office
Laval, Canada
Finland
Sanofi-aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-aventis Administrative Office
Berlin, Germany
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Spain
Sanofi-aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00811902    
Other Study ID Numbers: DRI10566
2008-001999-67 ( EudraCT Number )
First Posted: December 19, 2008    Key Record Dates
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Sanofi:
Multiple sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases