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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

December 18, 2008
January 28, 2016
December 2008
March 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00811902 on ClinicalTrials.gov Archive Site
Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
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
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Nerispirdine
    tablet, oral administration
    Other Name: HP184
  • Drug: placebo
    tablet, oral administration
  • Experimental: Nerispirdine 50mg
    Nerispirdine 50mg once daily for 14 weeks
    Intervention: Drug: Nerispirdine
  • Experimental: Nerispirdine 100mg
    Nerispirdine 100mg once daily for 14 weeks
    Intervention: Drug: Nerispirdine
  • Experimental: Nerispirdine 200mg
    Nerispirdine 200mg once daily for 14 weeks
    Intervention: Drug: Nerispirdine
  • Placebo Comparator: Placebo
    Placebo for Nerispirdine once daily for 14 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
405
March 2010
March 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   France,   Germany,   Norway,   Spain
 
NCT00811902
DRI10566, 2008-001999-67
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP