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

NCT00772525 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-02-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nerispirdine

form: tablet Route: oral

DRUG

Placebo

form: tablet Route: oral

Sponsors & Collaborators

Principal Investigators

  • Robert SERGOTT, MD · Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772525 on ClinicalTrials.gov