TABLE 1.
Trial | Registration number | Trial characteristic | Country (centers) | No. of patients | Intervention | Control | Primary outcomes | Follow up | ||
---|---|---|---|---|---|---|---|---|---|---|
Protocol | Age (% female) | Protocol | Age (% female) | |||||||
Dodick 2019 | NCT02275117 | Phase 2 | 4 countries (92) | 243 | 100 mg Eptinezumab | 36.7 (85%) | Placebo | 37.2 (90%) | 75% response rates | 12 weeks |
PROMISE-1 2020 | NCT02559895 | Phase 3 | 2 countries (84) | 445 | 100 mg Eptinezumab | 40.0 (80%) | Placebo | 39.9 (84%) | Change in MMDs | 12 weeks |
PROMISE-2 2020 | NCT02974153 | Phase 3 | 13 countries (128) | 722 | 100 mg Eptinezumab | 41.0 (86%) | Placebo | 39.6 (89%) | Change in MMDs | 12 weeks |
Sun 2016 | NCT01952574 | Phase 2 | 7 countries (59) | 267 | 70 mg Erenumab | 42.6 (77%) | Placebo | 41.4 (83%) | Change in MMDs | 12 weeks |
STRIVE 2017 | NCT02456740 | Phase 3 | Multiple countries (121) | 636 | 70 mg Erenumab | 41.1 (84.5%) | Placebo | 41.3 (85.9%) | Change in MMDs | 24 weeks |
Tepper 2017 | NCT02066415 | Phase 2 | 10 countries (69) | 477 | 70 mg Erenumab | 41.4 (87%) | Placebo | 42.1 (79%) | Change in MMDs | 12 weeks |
ARISE 2018 | NCT02483585 | Phase 3 | Multiple countries (69) | 577 | 70 mg Erenumab | 42 (85.7%) | Placebo | 42 (84.9%) | Change in MMDs | 12 weeks |
Sakai 2019 | NCT02630459 | Phase 2 | Japan (43) | 271 | 70 mg Erenumab | 44 (85.2%) | Placebo | 45 (86.8%) | Change in MMDs | 24 weeks |
Bigal 2015 | NCT02025556 | Phase 2 | United States (62) | 200 | 225 mg Fremanezumab | 40.8 (91%) | Placebo | 42.0 (88%) | Change in MMDs | 12 weeks |
Silberstein 2017 | NCT02621931 | Phase 3 | 9 countries (132) | 754 | 225 mg Fremanezumab | 40.6 (87%) | Placebo | 41.4 (88%) | Change in MHDs | 12 weeks |
Dodick 2018 | NCT02629861 | Phase 3 | 9 countries (123) | 584 | 225 mg Fremanezumab | 42.9 (84.1%) | Placebo | 41.3 (84.0%) | Change in MMDs | 12 weeks |
FOCUS 2019 | NCT03308968 | Phase 3 | 14 countries (104) | 562 | 225 mg Fremanezumab | 45.9 (84%) | Placebo | 46.8 (84%) | Change in MMDs | 12 weeks |
EVOLVE-1 2018 | NCT02614183 | Phase 3 | United States (90) | 646 | 120 mg Galcanezumab | 40.9 (85%) | Placebo | 41.3 (83.6%) | Change in MMDs | 24 weeks |
EVOLVE-2 2018 | NCT02614196 | Phase 3 | 11 countries (109) | 692 | 120 mg Galcanezumab | 40.9 (85.3%) | Placebo | 42.3 (85.7%) | Change in MMDs | 24 weeks |
REGAIN 2018 | NCT02614261 | Phase 3 | 12 countries (116) | 836 | 120 mg Galcanezumab | 39.7 (85%) | Placebo | 41.6 (87%) | Change in MMDs | 12 weeks |
Skljarevski 2018 | NCT02163993 | Phase 2 | United States (multiple centers) | 207 | 120 mg Galcanezumab | NA | Placebo | 39.5 (79.6%) | Change in MMDs | 12 weeks |
CONQUER 2020 | NCT03559257 | Phase 3 | 12 countries (64) | 462 | 120 mg Galcanezumab | 45.9 (84%) | Placebo | 45.7 (88%) | Change in MMDs | 12 weeks |
NCT02959177 | NCT02959177 | Phase 2 | Japan (47) | 345 | 120 mg Galcanezumab | NA | Placebo | NA | Change in MMDs | 24 weeks |
This data extracted from control group since data of all patients lacked. MMD: monthly migraine days; MHD: monthly headache days; USA: United States of America; NA: not applicable.