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

January 28, 2016 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Sanofi-Aventis Administrave Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1

placebo,1 day treatment period 1

50 mg Nerispirdine, 1 day treatment period 2

400 mg Nerispirdine, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral
Experimental: Sequence 2

placebo,1 day treatment period 1

400 mg Nerispirdine, 1 day treatment period 2

50 mg Nerispirdine, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral
Experimental: Sequence 3

50 mg Nerispirdine, 1 day treatment period 1

placebo, 1 day treatment period 2

400 mg Nerispirdine, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral
Experimental: Sequence 4

50 mg Nerispirdine, 1 day treatment period 1

400 mg Nerispirdine, 1 day treatment period 2

placebo, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral
Experimental: Sequence 5

400 mg Nerispirdine, 1 day treatment period 1

placebo, 1 day treatment period 2

50 mg Nerispirdine, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral
Experimental: Sequence 6

400 mg Nerispirdine, 1 day treatment period 1

50 mg Nerispirdine, 1 day treatment period 2

placebo, 1 day treatment period 3
Drug: Nerispirdine

form: tablet

Route: oral

Other Names:
  • HP184
Drug: Placebo

form: tablet

Route: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Evoked Potential (P100) latency
Time Frame: pre-dose and post-dose of each treatment intake (3)
pre-dose and post-dose of each treatment intake (3)

Secondary Outcome Measures

Outcome Measure
Time Frame
Pelli-Robson Contrast Sensitivity Score
Time Frame: pre-dose and post-dose of each treatment intake (3)
pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
Time Frame: pre-dose and post-dose of each treatment intake (3)
pre-dose and post-dose of each treatment intake (3)
Visual Evoked Potential (VEP) amplitude
Time Frame: pre-dose and post-dose of each treatment intake (3)
pre-dose and post-dose of each treatment intake (3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Principal Investigator: Robert SERGOTT, MD, Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 13, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT10573

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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