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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001999-67 | EudraCT Number |
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The primary objective is to assess the activity of nerispirdine in improving the ability to walk, in patients with multiple sclerosis (MS).
Secondary objectives:
Total duration per patient is approximately 19 weeks in total, comprising a 3-week screening period inclusive of a 2-week placebo run-in period, a 14-week treatment period, and a 2-week placebo run-out (follow-up) period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerispirdine 50mg | Experimental | Nerispirdine 50mg once daily for 14 weeks |
|
| Nerispirdine 100mg | Experimental | Nerispirdine 100mg once daily for 14 weeks |
|
| Nerispirdine 200mg | Experimental | Nerispirdine 200mg once daily for 14 weeks |
|
| Placebo | Placebo Comparator | Placebo for Nerispirdine once daily for 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerispirdine | Drug | tablet, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responder criterion based on consistency of improved response in walking speed on the Timed 25-Foot Walk (T25-FWT) | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to endpoint in the 12-item MS Walking Scale (MSWS-12) | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-aventis Administrative Office |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C101289 | nerispirdine |
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| placebo | Drug | tablet, oral administration |
|
| Laval |
| Canada |
| Sanofi-aventis Administrative Office | Helsinki | Finland |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Lysaker | Norway |
| Sanofi-aventis Administrative Office | Barcelona | Spain |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |