NCT00811902|CompletedPhase 2DMC

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.

Sanofi ClinicalTrials.gov

Compare

2 other identifiers

DRI105662008-001999-67

Study Type

interventional

Target

405

Locations

7 countries

Sites

Timeline

RegisteredDec 2008

StartedDec 2008

CompletionMar 2010

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

405

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline

Completed

Started Dec 2008

Shorter than P25 for phase_2 multiple-sclerosis

Geographic Reach

7 countries

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed

Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

December 18, 2008

Last Update Submit

January 28, 2016

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis

Outcome Measures

Primary Outcomes (1)

Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT)
14 weeks

Secondary Outcomes (1)

Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12)
14 weeks

Study Arms (4)

Nerispirdine 50mg

EXPERIMENTAL

Nerispirdine 50mg once daily for 14 weeks

Drug: Nerispirdine

Nerispirdine 100mg

EXPERIMENTAL

Nerispirdine 100mg once daily for 14 weeks

Drug: Nerispirdine

Nerispirdine 200mg

EXPERIMENTAL

Nerispirdine 200mg once daily for 14 weeks

Drug: Nerispirdine

Placebo

PLACEBO COMPARATOR

Placebo for Nerispirdine once daily for 14 weeks

Drug: placebo

Interventions

NerispirdineDRUG

tablet, oral administration

Also known as: HP184

Nerispirdine 100mgNerispirdine 200mgNerispirdine 50mg

placeboDRUG

tablet, oral administration

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Clinically definite MS (according to McDonald criteria),

You may not qualify if:

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.

Contact the study team to confirm eligibility.