Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01235221 | Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials. | PHASE3 | COMPLETED | 38 | — | — | Dec 1, 2010 | Jun 1, 2012 | Jul 4, 2014 | 5 | Canada |
| NCT01597297 | Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis. | PHASE2 | COMPLETED | 132 | — | — | Aug 1, 2012 | Aug 1, 2013 | Jan 9, 2017 | 23 | Belgium, Canada +4 |
| Arm | Type | Description |
|---|---|---|
| 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. |
| Fampridine-PR | EXPERIMENTAL | Prolonged-Release Fampridine (Fampridine-PR) 10 mg twice daily (every 12 hours) for up to 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matched placebo twice daily (every 12 hours) for up to 24 weeks. |
| Name | Type | Description |
|---|---|---|
| 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. |
| BIIB041 (PR Fampridine) | DRUG | 10 mg twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food. |
| Placebo | OTHER | Twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food. |
Key Inclusion Criteria : 1. Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR. 2. Willing to comply with the required scheduling and assessments of the protocol. 3. Female subjects of childbearing potential, r...