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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
31
form: tablet Route: oral
form: tablet Route: oral
Sanofi-Aventis Administrave Office
Bridgewater, New Jersey, United States
Visual Evoked Potential (P100) latency
Time frame: pre-dose and post-dose of each treatment intake (3)
Pelli-Robson Contrast Sensitivity Score
Time frame: pre-dose and post-dose of each treatment intake (3)
Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score
Time frame: pre-dose and post-dose of each treatment intake (3)
Visual Evoked Potential (VEP) amplitude
Time frame: pre-dose and post-dose of each treatment intake (3)
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