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

Multiple Sclerosis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772525
• Other study ID #: ACT10573
• Status: Completed
• Phase: Phase 2
• First received: October 13, 2008
• Last updated: January 28, 2016
• Start date: September 2008
• Est. completion date: June 2009

Study information

• Verified date: January 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Nerve
• Sclerosis

Intervention

Drug:
• Nerispirdine
form: tablet Route: oral
• Placebo
form: tablet Route: oral

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrave Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Evoked Potential (P100) latency		pre-dose and post-dose of each treatment intake (3)	Yes
Secondary	Pelli-Robson Contrast Sensitivity Score		pre-dose and post-dose of each treatment intake (3)	Yes
Secondary	Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score		pre-dose and post-dose of each treatment intake (3)	Yes
Secondary	Visual Evoked Potential (VEP) amplitude		pre-dose and post-dose of each treatment intake (3)	Yes