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

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

Official Title
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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

Conditions
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Multiple Sclerosis, Optic Nerve, Neuritis

Intervention / Treatment
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* Drug: Nerispirdine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|
| Experimental: Sequence 2<br>placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|
| Experimental: Sequence 3<br>50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|
| Experimental: Sequence 4<br>50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|
| Experimental: Sequence 5<br>400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|
| Experimental: Sequence 6<br>400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 | Drug: Nerispirdine<br>* form: tablet Route: oral<br>* Other names: HP184;Drug: Placebo<br>* form: tablet Route: oral<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual acuity, Contrast sensitivity, Visual Evoked Potentials, Optical Coherence Tomography