Endpoint | Rimegepant 75 mg n = 537 | Placebo n = 537 | Risk Differenceb (95% CI) | p valuec |
---|---|---|---|---|
Co-Primary | ||||
Pain freedom at 2 h post-dose | 98 (18.2%) | 57 (10.6%) | 7.6 (3.5, 11.8) | 0.0004 |
MBS freedom at 2 h post-dose | 258 (48.0%) | 171 (31.8%) | 16.2 (10.4, 22.0) | < 0.0001 |
Key Secondary | ||||
Pain relief at 2 h post-dose | 351 (65.4%) | 256 (47.7%) | 17.8 (12.0, 23.7) | < 0.0001 |
Normal function at 2 h post-dose d | 176 (38.5%) | 110 (23.8%) | 14.7 (8.8, 20.6) | < 0.0001 |
Rescue Medication use within 24 h post-dose | 28 (5.2%) | 75 (14.0%) | −8.9 (−12.4, −5.4) | < 0.0001 |
Sustained pain freedom from 2 to 24 h post-dose | 82 (15.3%) | 43 (8.0%) | 7.2 (3.4, 11.1) | 0.0002 |
Sustained pain freedom from 2 to 48 h post-dose | 78 (14.5%) | 39 (7.3%) | 7.2 (3.5, 10.9) | 0.0001 |