Single Oral Doses Study ofNerispirdineon Visual Function in Patients With Multiple Sclerosis
Posted Nov 17 2009 10:20pm
The primary objective of the study is 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 include 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. Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) are 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.
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