This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

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

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
Intervention Model: Parallel Assignment
Masking: Double Blind (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.

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 ]

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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00811902

United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
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
Sponsors and Collaborators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi Identifier: NCT00811902     History of Changes
Other Study ID Numbers: DRI10566
2008-001999-67 ( EudraCT Number )
Study First Received: December 18, 2008
Last Updated: January 28, 2016

Keywords provided by Sanofi:
Multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on July 24, 2017