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
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.
The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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