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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02219932 | Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis | PHASE3 | COMPLETED | 646 | — | — | Sep 1, 2014 | Feb 1, 2016 | Mar 27, 2017 | 87 | United States, Bulgaria +9 |
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 ...