Approval Probability
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ML Risk
Also known as BIIB041 (Fampridine-PR), BIIB041 (PR Fampridine), BIIB041 (Fampridine-SR), BIIB041 (fampridine), Fampridine, Fampyra, Ampyra, dalfampridine
BIIB041 · 4 trials · 5 indications
MSWS-12 is a participant self-assessment of the walking limitations due to MS during the past 2 weeks. It contains 12 items that measure the impact of MS on walking. Items are summed to generate a total score and transformed to a scale with a range of 0 to 100, where higher scores indicate greater impact on walking. A responder is defined as a participant with a mean improvement of at least 8 points over 24 weeks compared to baseline. Baseline is defined as the mean at Screening and Day 1 visits. If a participant has a mean MSWS-12 score of \< 0.5 over the double-blind period, and a baseline MSWS-12 score of \< 8 points, the participant is counted as a responder. A participant who indicates they cannot walk at all on MSWS-12 during any double-blind visit, and who shows severe disability and an inability to walk on other efficacy assessments is counted as a non-responder. Estimated proportion obtained from binomial proportions.
| Arm | Type | Description |
|---|---|---|
| Fampridine 10 mg BID | EXPERIMENTAL | Prolonged-release fampridine 10 mg twice daily (BID) for up to 24 weeks |
| Placebo | PLACEBO_COMPARATOR | Matched placebo 10 mg BID for up to 24 weeks |
| Part A Placebo | PLACEBO_COMPARATOR | Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. |
| Part A prolonged-release fampridine | EXPERIMENTAL | Part A: All participants will receive placebo orally twice daily for the first 2 weeks and then be randomized to receive prolonged-release fampridine 10 mg or matching placebo tablets orally twice daily for up to 14 weeks. |
| Part B prolonged-release fampridine | EXPERIMENTAL | Part B: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily for up to 52 weeks. |
| Part C prolonged-release fampridine | EXPERIMENTAL | Part C: Eligible participants will receive open label treatment with prolonged-release fampridine 10mg orally twice daily until marketed product is available. |
| 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. |
| Name | Type | Description |
|---|---|---|
| fampridine | DRUG | - |
| Placebo | DRUG | Matched placebo |
| BIIB041 (fampridine) | DRUG | fampridine prolonged-release tablets |
| 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. |
Key Inclusion Criteria: * Must have a diagnosis of primary-progressive, secondary-progressive, progressive-relapsing, or relapsing-remitting MS per revised McDonald Committee criteria \[McDonald 2001; Polman 2005\] as defined by Lublin and Reingold \[Lublin and Reingold 1996\] of at least 3 months ...
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BIIB041 is an investigational oral small molecule being studied for multiple sclerosis, including relapsing-remitting, secondary progressive, primary progressive, and remittent progressive forms. It is being developed to assess effects on walking ability and balance in people with MS. It is not described as approved and remains in clinical development.
BIIB041 is developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program evaluating the drug in multiple sclerosis, including studies conducted in Japan, Canada, and several European countries.
BIIB041 is in Phase 3 development. Two completed Phase 3 trials have evaluated the drug, one in Japanese participants with multiple sclerosis and one open-label extension study in Canadian participants. A Phase 2 exploratory study of walking ability and balance has also been completed. The drug is investigational and not described as approved.
BIIB041 has been studied in completed trials including NCT01917019, a Phase 3 safety and efficacy study in Japanese participants with multiple sclerosis; NCT01597297, a Phase 2 exploratory study of walking ability and balance; and NCT01235221, a Phase 3 open-label extension study in Canadian participants. All three trials are completed.
Yes. BIIB041 is also known as fampridine-PR, PR fampridine, fampridine-SR, and fampridine. These names refer to the same prolonged-release or sustained-release oral fampridine formulation developed by Biogen for multiple sclerosis. Searches for any of these alternative names refer to the same investigational asset.
The BIIB041 clinical program enrolled 170 participants in total across its completed trials. The Phase 3 Japanese study NCT01917019 enrolled 101 participants, the Phase 2 exploratory study NCT01597297 enrolled 132 participants, and the Phase 3 Canadian open-label extension NCT01235221 enrolled 38 participants.