Variable | EVOLVE-1 and EVOLVE-2 (Episodic Migraine Trials) | REGAIN (Chronic Migraine Trial) | ||||||
---|---|---|---|---|---|---|---|---|
PBO N = 894 | GMB 120 mg N = 444 | GMB 240 mg N = 435 | Total N = 1773 | PBO N = 558 | GMB 120 mg N = 278 | GMB 240 mg N = 277 | Total N = 1113 | |
Age, years, mean (SD) | 41.5 (11.3) | 40.6 (11.4) | 40.1 (11.5) | 41.0 (11.4) | 41.6 (12.1) | 39.7 (11.9)* | 41.1 (12.4) | 41.0 (12.1) |
Female, n (%) | 755 (84.5) | 378 (85.1) | 366 (84.1) | 1499 (84.6) | 483 (87) | 237 (85) | 226 (82) | 946 (85.0) |
Years since migraine diagnosis, mean (SD) | 20.3 (12.3) | 20.7 (12.1) | 19.5 (11.9) | 20.2 (12.2) | 21.9 (12.9) | 20.4 (12.7) | 20.1 (12.7)* | 21.1 (12.8)* |
Number of migraine headache days/month | 10.9 (2.0) | 10.9 (2.0) | 10.7 (2.0) | 10.8 (2.0) | 19.6 (4.6) | 19.4 (4.3) | 19.2 (4.6) | 19.4 (4.5) |
Number of severe migraine headache days/month | 2.6 (2.4) | 2.5 (2.3) | 2.7 (2.3) | 2.6 (2.3) | 6.6 (5.2) | 6.7 (4.9) | 6.6 (4.8) | 6.6 (5.0) |
Number of moderate-severe migraine headache days | 7.4 (3.0) | 7.4 (3.0) | 7.5 (3.1) | 7.4 (3.1) | 16.1 (5.4) | 16.0 (5.2) | 15.7 (5.4) | 16.0 (5.4) |
Mean severity of migraine headache daysa | 2.1 (0.4) | 2.1 (0.4) | 2.1 (0.4) | 2.1 (0.4) | 2.2 (0.4) | 2.2 (0.4) | 2.2 (0.4) | 2.2 (0.4) |
Number of migraine headache days with aura | 3.1 (3.8) | 2.8 (3.4) | 3.1 (3.6) | 3.0 (3.7) | 5.0 (6.9) | 5.3 (7.3) | 4.8 (7.0) | 5.0 (7.0) |
Number of migraine headache days with nausea and/or vomiting | 4.6 (3.4) | 4.7 (3.4) | 4.8 (3.3) | 4.7 (3.4) | 9.2 (6.9) | 8.8 (6.3) | 8.1 (6.5)* | 8.8 (6.7) |
Number of migraine headache days with photophobia and phonophobia | 8.4 (3.5) | 8.1 (3.6) | 8.1 (3.6) | 8.3 (3.5) | 15.2 (7.2) | 14.8 (7.0) | 14.0 (7.6)* | 14.8 (7.3) |
Number of migraine headache days with prodromal symptoms | 3.9 (3.8) | 3.8 (3.8) | 3.7 (3.7) | 3.9 (3.8) | 6.8 (7.3) | 7.3 (7.5) | 7.1 (7.3) | 7.0 (7.4) |
Proportion of migraine headache days with nausea and vomiting | 40.4 (30.1) | 41.8 (32.0) | 42.3 (30.2) | 41.2 (30.6) | 46.4 (31.3) | 44.7 (29.3) | 41.5 (30.3) | 44.8 (30.6) |
Proportion of migraine headache days with photophobia and phonophobia | 74.5 (30.2) | 72.8 (31.8) | 73.9 (30.7) | 73.9 (30.7) | 76.4 (29.6) | 75.0 (29.7) | 71.6 (32.7) | 74.8 (30.5) |