Table 1. Description of Trials and Characteristics of Trial Participants.
F: Female, M: Male, OD: Once daily, BID: Twice daily, SD: Single Dose, CFB: change from baseline, MMDs: Monthly migraine days, MHDs: Monthly headache days, TRAEs: Treatment-related adverse events, SAEs: Serious adverse events, OR: Odds ratio, CI: Confidence interval; *p <0.05, **p<0.001, vs. placebo; aThe data are presented as difference from placebo.
| Study | Publication Date | Type of study | Phase | Doses | No. of Participants | Sex | Mean Age (standard deviation) | White (%) | Mean BMI (standard deviation) |
|---|---|---|---|---|---|---|---|---|---|
| Ankrom et al.9 | April, 2020 | Open‐label, 2‐period, fixed‐sequence, single‐site study | I | 60 mg OD | 26 | F: 26 M: 0 | 56 (5.1) | 88.5 | 26.4 (2.5) |
| Goadsby et al.10 | August, 2020 | Randomized, double-blind, multicenter clinical trials | II/III | 10 mg OD | 93 | F: 82 M: 11 | 39·4 (12·4) | 74 | 29.9 (7.3) |
| 30 mg OD | 183 | F: 166 M: 17 | 41·0 (13·6) | 79 | 30.0 (7.1) | ||||
| 60 mg OD | 186 | F: 158 M: 28 | 40·4 (11·7) | 72 | 30.0 (7.8) | ||||
| 30 mg BID | 86 | F: 73 M: 13 | 38·5 (11·2) | 85 | 29.7 (7.2) | ||||
| 60 mg BID | 91 | F: 83 M: 8 | 39·7 (11·9) | 78 | 30.4 (7.4) | ||||
| Placebo | 186 | F: 154 M: 32 | 40·5 (11·7) | 74 | 30.4 (7.6) | ||||
| Min et al.11 | November, 2020 | Randomized, double-blind, placebo-controlled | I | 170 mg OD | 23 | F: 4 M:19 | 37.1 (9.5) | 39.1 | - |
| Placebo | 11 | F:3 M:8 | 39.8 (9.3) | 54.5 | - | ||||
| Boinpally et al.12 | May, 2021 | Randomized, single‐center, double‐blind, 3‐period, 6‐sequence, single‐dose, crossover trial | I | 300 mg SD | 60 | F: 32 M: 28 | 33.6 (7.3) | 56.7 | 25.7 (2.9) |
| Placebo | 59 | F: 31 M: 28 | 33.5 (7.3) | 57.6 | 25.6 (2.9) | ||||
| Ailani et al.13 | August, 2021 | Randomized, double-blind, multicenter clinical trials | III | 10 mg OD | 221 | F: 200 M: 21 | 41.4 (12.1) | 81.9 | 30.3 (7.6) |
| 30 mg OD | 228 | F: 204 M: 24 | 42.1 (11.7) | White: 81.1 | 31.1 (7.6) | ||||
| 60 mg OD | 231 | F: 199 M: 32 | 42.5 (12.4) | White: 83.1 | 29.9 (7.3) | ||||
| Placebo | 222 | F: 198 M: 24 | 40.3 (12.8) | White: 87.4 | 30.8 (8.7) | ||||
| Schwedt et al.14 | January, 2022 | Randomized, double-blind clinical trial | III | 10 mg OD | 221 | F: 200 M: 21 | 41.4 (12.1) | White: 81.9 | 30.4 (7.6) |
| 30 mg OD | 228 | F: 204 M: 24 | 42.1 (11.7) | White: 81.1 | 31.2 (7.6) | ||||
| 60 mg OD | 231 | F: 199 M: 32 | 42.5 (12.4) | White: 83.1 | 29.9 (7.3) | ||||
| Placebo | 222 | F: 198 M: 24 | 40.3 (12.8) | White: 87.4 | 30.8 (8.7) | ||||
| Lipton et al.15 | June, 2022 | Randomized, double blind, placebo-controlled clinical trial | III | 10 mg OD | 221 | F:200 M:21 | 41.4 (12.1) | White : 81.9 | 30.4 (7.6) |
| 30 mg OD | 228 | F:204 M:24 | 42.1 (11.7) | White : 81.1 | 31.2 (7.6) | ||||
| 60 mg OD | 231 | F:199 M:32 | 42.5 (12.4) | White : 83.1 | 29.9 (7.3) | ||||
| Placebo | 222 | F:198 M:24 | 40.3 (12.8) | White : 87.4 | 30.8 (8.7) | ||||
| Klein et al.16 | January, 2023 | Randomized, open-label, multicenter extension trial | III | 60 mg OD | 685 | F:604 M:81 | 41.8 (12.3) | White : 84.4 | 30.58 (7.82) |
| Ashina et al.17 | January, 2023 | Randomized, open-label, multicenter clinical trial | III | 60 mg OD | 546 | F:479 M:64 | 42.5 (12.0) | 76.6 | 30.6 (8.0) |
| Placebo | 198 | F:172 M:24 | 41.1 (12.1) | 74 | 30.6 (8.0) |