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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-03-31

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

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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

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nerispirdine 50mg

Nerispirdine 50mg once daily for 14 weeks

Group Type EXPERIMENTAL

Nerispirdine

Intervention Type DRUG

tablet, oral administration

Nerispirdine 100mg

Nerispirdine 100mg once daily for 14 weeks

Group Type EXPERIMENTAL

Nerispirdine

Intervention Type DRUG

tablet, oral administration

Nerispirdine 200mg

Nerispirdine 200mg once daily for 14 weeks

Group Type EXPERIMENTAL

Nerispirdine

Intervention Type DRUG

tablet, oral administration

Placebo

Placebo for Nerispirdine once daily for 14 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablet, oral administration

Interventions

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Nerispirdine

tablet, oral administration

Intervention Type DRUG

placebo

tablet, oral administration

Intervention Type DRUG

Other Intervention Names

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HP184

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No