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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02917187 | A Phase 2a Study of BIIB074 in the Treatment of Erythromelalgia | PHASE2 | COMPLETED | 8 | — | — | Sep 9, 2016 | Jan 5, 2017 | Jan 10, 2018 | 5 | United States |
11-point Pain Intensity Numerical Rating Scale (PI-NRS) is used to assess EM paroxysmal pain. PI-NRS is an 11-point pain intensity numerical rating scale, where 0=no pain and 10=worst possible pain. Weekly average is defined as the total of severity scores during a week divided by the total number of paroxysms during that week.
| Arm | Type | Description |
|---|---|---|
| Randomized Group 1 | EXPERIMENTAL | After two week run-in, BIIB074 three times a day (TID) followed by placebo (TID) after two week washout period |
| Randomized Group 2 | EXPERIMENTAL | After two week run-in, Placebo three times a day (TID) followed by BIIB074 (TID) after two week washout period |
| Name | Type | Description |
|---|---|---|
| BIIB074 | DRUG | Administered as specified in the treatment arm |
| Placebo | DRUG | Matched placebo |
Key Inclusion Criteria: * A diagnosis of primary inherited EM with family history of EM made at least 3 months from initial diagnosis. * Failed at least one prior treatment for EM (defined as an inadequate response or intolerance to treatment). * Approved concomitant medications must have been stab...