NCT00772525

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Multiple Sclerosis
• Optic Nerve
• Neuritis

Interventions

Type	Name	Description
DRUG	Nerispirdine	form: tablet Route: oral
DRUG	Placebo	form: tablet Route: oral

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2008-10-15
• Last updated: 2016-02-26

Locations

1 site across 1 country: United States