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Also known as dalfampridine, Ampyra, Fampyra, fampridine prolonged-release tablets, BIIB041
fampridine · 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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Fampridine is a small molecule drug developed by Biogen Inc. (BIIB) for multiple sclerosis. It is a prolonged-release formulation studied in a Phase 3 trial for efficacy and safety in participants with multiple sclerosis. The trial, NCT02219932, completed with 646 participants.
Fampridine targets several potassium channels, specifically KCNQ1, KCND3, KCNH2, KCNA2, KCNA1, and KCNQ2. It acts as a blocker of these channels. This mechanism is relevant to its development in multiple sclerosis.
Fampridine is being developed by Biogen Inc., which trades under the ticker BIIB. Biogen is the company responsible for the clinical development of this small molecule for multiple sclerosis.
Fampridine is in Phase 3 development for multiple sclerosis. A completed Phase 3 trial, NCT02219932, evaluated its efficacy and safety. The drug is investigational and has not been approved by the FDA for this indication.
Fampridine has been studied in one completed Phase 3 clinical trial, NCT02219932, titled "Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis." The trial enrolled 646 participants across multiple countries and was randomized, double-blind, and placebo-controlled.