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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Nerispirdine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811902

2008-001999-67 (EudraCT Number)

DRI10566

Details and patient eligibility

About

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

Full 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

Enrollment: 405 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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405 participants in 4 patient groups, including a placebo group

Nerispirdine 50mg

Experimental group

Description:

Nerispirdine 50mg once daily for 14 weeks

Treatment:

Drug: Nerispirdine

Nerispirdine 100mg

Experimental group

Description:

Nerispirdine 100mg once daily for 14 weeks

Treatment:

Drug: Nerispirdine

Nerispirdine 200mg

Experimental group

Description:

Nerispirdine 200mg once daily for 14 weeks

Treatment:

Drug: Nerispirdine

Placebo

Placebo Comparator group

Description:

Placebo for Nerispirdine once daily for 14 weeks

Treatment:

Drug: placebo