Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | placebo,1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
|
| Sequence 2 | Experimental | placebo,1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
|
| Sequence 3 | Experimental | 50 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 400 mg Nerispirdine, 1 day treatment period 3 |
|
| Sequence 4 | Experimental | 50 mg Nerispirdine, 1 day treatment period 1 400 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
|
| Sequence 5 | Experimental | 400 mg Nerispirdine, 1 day treatment period 1 placebo, 1 day treatment period 2 50 mg Nerispirdine, 1 day treatment period 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerispirdine | Drug | form: tablet Route: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Evoked Potential (P100) latency | pre-dose and post-dose of each treatment intake (3) |
| Measure | Description | Time Frame |
|---|---|---|
| Pelli-Robson Contrast Sensitivity Score | pre-dose and post-dose of each treatment intake (3) | |
| Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score | pre-dose and post-dose of each treatment intake (3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert SERGOTT, MD | Wills Eye Institute, Thomas Jefferson University, Philadelphia Pennsylvania, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrave Office | Bridgewater | New Jersey | 08807 | United States |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C101289 | nerispirdine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sequence 6 | Experimental | 400 mg Nerispirdine, 1 day treatment period 1 50 mg Nerispirdine, 1 day treatment period 2 placebo, 1 day treatment period 3 |
|
|
| Placebo | Drug | form: tablet Route: oral |
|
| Visual Evoked Potential (VEP) amplitude | pre-dose and post-dose of each treatment intake (3) |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |