Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title: A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis

Status Completed

Clinical Trial Summary

The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.

Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).

Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.

Clinical Trial Description

The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Nerve
• Sclerosis

• NCT number: NCT00772525
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Completion date: June 2009