Clinical trial NCT00772525: Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Optic Nerve
Neuritis
Keywords: Visual acuity
Contrast sensitivity
Visual Evoked Potentials
Optical Coherence Tomography
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Evoked Potential (P100) latency
timeFrame: pre-dose and post-dose of each treatment intake (3)
Secondary outcomes:
measure: Pelli-Robson Contrast Sensitivity Score
timeFrame: pre-dose and post-dose of each treatment intake (3)
measure: Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
timeFrame: pre-dose and post-dose of each treatment intake (3)
measure: Visual Evoked Potential (VEP) amplitude
timeFrame: pre-dose and post-dose of each treatment intake (3)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrave Office
state: New Jersey
Study officials:
affiliation: Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA
name: Robert SERGOTT, MD
role: PRINCIPAL_INVESTIGATOR
References: