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| Name | Class |
|---|---|
| Acorda Therapeutics | INDUSTRY |
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The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple sclerosis (MS) who previously participated in the registrational and extension studies conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT) and NCT00649792 (MS-F204EXT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB041 (Fampridine-SR) | Experimental | Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB041 (Fampridine-SR) | Drug | 10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments | From Screening (Day 0) to Termination (Month 27) |
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Key Inclusion Criteria :
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Center | Calgary | Alberta | Canada | |||
| University of British Columbia |
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|
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| Vancouver |
| British Columbia |
| Canada |
| River Valley Health | Fredericton | New Brunswick | Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | Canada |
| Ottawa Hospital General Campus | Ottawa | Ontario | Canada |
| 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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