Efficacy, Safety, and Tolerability of Nerispirdine in Patients With Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2008 |
| End Date: | March 2010 |
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
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
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
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.
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