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BIIB041 · 4 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| 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. |
| Placebo | PLACEBO_COMPARATOR | Matched placebo twice daily (every 12 hours) for up to 24 weeks. |
| Chinese Subpopulation: Fampridine-PR 10 mg | EXPERIMENTAL | Chinese ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
| Japanese Subpopulation: Fampridine-PR 10mg | EXPERIMENTAL | Japanese ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
| Caucasian Subpopulation: Fampridine-PR 10mg | EXPERIMENTAL | Caucasian ethnic participants were administered a single dose of Fampridine-PR 10 mgs |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | matching placebo tablets |
| 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. |
| BIIB041 (Fampridine-PR) | DRUG | A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants |
Key Inclusion Criteria: Part A To be eligible to participate in Part A, candidates must meet the following eligibility criteria at screening or at the timepoint specified in the individual eligibility criterion listed (potential subjects who fail screening may be rescreened 1 time): 1. Must have ...
BIIB041, also known as fampridine, is an investigational small molecule being studied for the treatment of multiple sclerosis (MS), including relapsing-remitting, secondary progressive, primary progressive, and remittent progressive forms. It has also been evaluated in healthy volunteers for pharmacokinetic and safety studies.
BIIB041 is a small molecule that contains fampridine, a potassium channel blocker. By blocking potassium channels, it is thought to improve nerve signal conduction in demyelinated nerves, which may help improve walking ability in people with multiple sclerosis.
BIIB041 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical trials to evaluate the safety and efficacy of this oral fampridine formulation in multiple sclerosis patients.
BIIB041 is in clinical development, with trials completed in Phase 1, Phase 2, and Phase 3. The most advanced completed trial is a Phase 3 study in Japanese participants with multiple sclerosis. However, BIIB041 is not yet approved and remains investigational.
BIIB041 has been studied in several completed trials, including NCT01215084 (Phase 1 PK study in healthy volunteers), NCT01235221 (Phase 3 open-label extension in Canadian MS patients), NCT01597297 (Phase 2 exploratory study on walking ability), and NCT01917019 (Phase 3 safety and efficacy study in Japanese MS patients).
Yes, BIIB041 is the same as fampridine, specifically an oral prolonged-release or sustained-release formulation of fampridine. Clinical trials for BIIB041 have evaluated this formulation in healthy volunteers and in patients with multiple sclerosis to assess its safety, tolerability, and effects on walking.