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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Nerispirdine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nerispirdine 50mg<br>Nerispirdine 50mg once daily for 14 weeks | Drug: Nerispirdine<br>* tablet, oral administration<br>* Other names: HP184;|
| Experimental: Nerispirdine 100mg<br>Nerispirdine 100mg once daily for 14 weeks | Drug: Nerispirdine<br>* tablet, oral administration<br>* Other names: HP184;|
| Experimental: Nerispirdine 200mg<br>Nerispirdine 200mg once daily for 14 weeks | Drug: Nerispirdine<br>* tablet, oral administration<br>* Other names: HP184;|
| Placebo Comparator: Placebo<br>Placebo for Nerispirdine once daily for 14 weeks | Drug: placebo<br>* tablet, oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT) |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) |  | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis