Table 2.
Efficacy of rimegepant for the preventive treatment of migraine in a phase II/III trial
| Endpoint [37] | RIM (n = 348) | PL (n = 347) | LSM between-group difference (95% CI) |
|---|---|---|---|
| Change from BL in mean no. of MMDs during wks 9–12a | − 4.3** | − 3.5 | − 0.8 (− 1.5 to − 0.2) |
| ≥ 50% reduction in mean no. of moderate/severe MMDs during wks 9–12 (% pts) | 49* | 41 | 8 (0 to 15) |
| Change from BL in mean no. of MMDs during wks 1–12 | − 3.6** | − 2.7 | − 0.8 (− 1.3 to − 0.3) |
| Mean no. of rescue medication days/month during wks 9–12 | 3.7 | 4.0 | − 0.2 (− 0.8 to 0.3) |
| Change from BL in mean no. of MMDs during wks 1–4 | − 2.9†† | − 1.7 | − 1.2 (− 1.7 to − 0.6) |
| Change from BL in MSQ role function (restrictive domain score) at wk 12b | 18.0† | 14.6 | 3.5 (0.2 to 6.7) |
| Change from BL in MIDAS total score at wk 12b | − 11.8 | − 11.7 | − 0.1 (− 4.7 to 4.5) |
Efficacy analyses were performed in the efficacy-evaluable population
BL baseline, LSM least squares mean, MIDAS Migraine Disability Assessment, MMDs monthly migraine days, MSQ Migraine-Specific Quality-of-Life Questionnaire, PL placebo, pts patients, RIM rimegepant, wk(s) week(s)
*p < 0.05, **p < 0.01 vs PL; †p < 0.05, ††p < 0.0001 (nominal) vs PL
aPrimary endpoint
bAssessed in 269 RIM and 266 PL pts who completed the questionnaire within the prespecified analysis window (wks 10–13)