Status:
COMPLETED
Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Optic Nerve
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Po...
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
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00772525
Start Date
September 1 2008
End Date
June 1 2009
Last Update
February 26 2016
Active Locations (1)
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1
Sanofi-Aventis Administrave Office
Bridgewater, New Jersey, United States, 08807