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fampridine · 1 trial · 1 indication
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 |
| Name | Type | Description |
|---|---|---|
| fampridine | DRUG | - |
| Placebo | DRUG | Matched placebo |
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 ...
Fampridine is an investigational small molecule being studied for the treatment of Multiple Sclerosis. It is formulated as a prolonged-release tablet and is being evaluated for its efficacy and safety in improving symptoms associated with the condition. The drug is currently in Phase 3 clinical development.
Fampridine is a potassium channel blocker. By blocking these channels, it is thought to improve nerve signal conduction in demyelinated nerves, which may help restore function in patients with Multiple Sclerosis. This mechanism is the basis for its investigation as a treatment for the disease.
Fampridine is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting the clinical trials for this drug, which is currently in Phase 3 development for Multiple Sclerosis.
Fampridine is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied for the treatment of Multiple Sclerosis, and its Phase 3 trial has been completed.
Fampridine has one completed Phase 3 clinical trial registered as NCT02219932. This study, titled "Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis," enrolled 646 participants across multiple countries including the United States, Bulgaria, Czechia, Finland, Italy, Lithuania, Netherlands, Poland, Russia, Serbia, and the United Kingdom.
Fampridine is being studied in a prolonged-release formulation. The clinical trial NCT02219932 specifically evaluates prolonged-release fampridine, indicating that this formulation is the subject of the Phase 3 study. The drug is being developed by Biogen for Multiple Sclerosis.