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
Overview
- Phase
- Phase 2
- Intervention
- Nerispirdine
- Conditions
- Multiple Sclerosis
- Sponsor
- Sanofi
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Visual Evoked Potential (P100) latency
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Sequence 1
placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 1
placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Intervention: Placebo
Sequence 2
placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 2
placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Intervention: Placebo
Sequence 3
50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 3
50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3
Intervention: Placebo
Sequence 4
50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 4
50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3
Intervention: Placebo
Sequence 5
400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 5
400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3
Intervention: Placebo
Sequence 6
400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3
Intervention: Nerispirdine
Sequence 6
400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3
Intervention: Placebo
Outcomes
Primary Outcomes
Visual Evoked Potential (P100) latency
Time Frame: pre-dose and post-dose of each treatment intake (3)
Secondary Outcomes
- Pelli-Robson Contrast Sensitivity Score(pre-dose and post-dose of each treatment intake (3))
- Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score(pre-dose and post-dose of each treatment intake (3))
- Visual Evoked Potential (VEP) amplitude(pre-dose and post-dose of each treatment intake (3))