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

NCT ID: NCT00772525

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sequence 1

placebo,1 day treatment period 1

50 mg Nerispirdine, 1 day treatment period 2

400 mg Nerispirdine, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Sequence 2

placebo,1 day treatment period 1

400 mg Nerispirdine, 1 day treatment period 2

50 mg Nerispirdine, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Sequence 3

50 mg Nerispirdine, 1 day treatment period 1

placebo, 1 day treatment period 2

400 mg Nerispirdine, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Sequence 4

50 mg Nerispirdine, 1 day treatment period 1

400 mg Nerispirdine, 1 day treatment period 2

placebo, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Sequence 5

400 mg Nerispirdine, 1 day treatment period 1

placebo, 1 day treatment period 2

50 mg Nerispirdine, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Sequence 6

400 mg Nerispirdine, 1 day treatment period 1

50 mg Nerispirdine, 1 day treatment period 2

placebo, 1 day treatment period 3

Group Type: EXPERIMENTAL

Nerispirdine

Intervention Type: DRUG

form: tablet

Route: oral

Placebo

Intervention Type: DRUG

form: tablet

Route: oral

Interventions

Nerispirdine

form: tablet

Route: oral

Intervention Type: DRUG

Placebo

form: tablet

Route: oral

Intervention Type: DRUG

Other Intervention Names

HP184

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert SERGOTT, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA

Locations

Sanofi-Aventis Administrave Office

Bridgewater, New Jersey, United States

Countries

United States

Other Identifiers

ACT10573

Identifier Type: -

Identifier Source: org_study_id