Single Oral Doses Study of Nerispirdine on Visual Function in Patients With Multiple Sclerosis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2008 |
| End Date: | June 2009 |
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.
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 participation were to be 5 weeks.
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.
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