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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00811902

Enrollment

405

Registered

2008-12-19

Start date

2008-12-31

Completion date

2010-03-31

Last updated

2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis

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

Detailed description

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

Interventions

DRUGNerispirdine

tablet, oral administration

DRUGplacebo

tablet, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

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

Countries

Canada, Finland, France, Germany, Norway, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026