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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00811902
First received: December 18, 2008
Last updated: December 15, 2010
Last verified: December 2010

December 18, 2008
December 15, 2010
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
Not Provided
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 (HP184)
    oral administration
  • Drug: placebo
    oral administration
  • Experimental: 1
    50 mg
    Intervention: Drug: Nerispirdine (HP184)
  • Experimental: 2
    100 mg
    Intervention: Drug: Nerispirdine (HP184)
  • Experimental: 3
    200 mg
    Intervention: Drug: Nerispirdine (HP184)
  • Placebo Comparator: 4
    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
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   France,   Germany,   Norway,   Spain
 
NCT00811902
DRI10566, EudraCT:2008-001999-67
Yes
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2010

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