Skip to main content
OpenTrials
Completed

NCT Number: NCT00772525

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Neuritis Neuromuscular Diseases Optic Nerve Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrave Office

Bridgewater, New Jersey, 08807, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.

Exclusion criteria

  • Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
  • No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
  • Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
  • Previously exposed to 3,4-diaminopyridine or 4-aminopyridine

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Nerispirdine

Drug

form: tablet

Route: oral

Other names: HP184

Placebo

Drug

form: tablet

Route: oral

Primary outcomes

  1. Visual Evoked Potential (P100) latency

    Time frame: pre-dose and post-dose of each treatment intake (3)

Secondary outcomes

  1. Pelli-Robson Contrast Sensitivity Score

    Time frame: pre-dose and post-dose of each treatment intake (3)

  2. Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score

    Time frame: pre-dose and post-dose of each treatment intake (3)

  3. Visual Evoked Potential (VEP) amplitude

    Time frame: pre-dose and post-dose of each treatment intake (3)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.