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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00811902
First received: December 18, 2008
Last updated: January 28, 2016
Last verified: January 2016
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Nerispirdine
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Enrollment: 405
Study Start Date: December 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811902

Locations
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
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00811902     History of Changes
Other Study ID Numbers: DRI10566  2008-001999-67 
Study First Received: December 18, 2008
Last Updated: January 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Multiple sclerosis

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 23, 2016