Table 1 Baseline characteristics in patients with chronic migraine or episodic migraine who had failed 3–4 preventive medication categories due to inadequate efficacy, or safety or tolerability reasons within the last 10 years
Total population | CM | EM | ||||
|---|---|---|---|---|---|---|
Placebo n = 87 | GMB 120 mg n = 99 | Placebo n = 43 | GMB 120 mg n = 43 | Placebo n = 44 | GMB 120 mg n = 56 | |
Demographics | ||||||
Age, years, mean (SD) | 46.2 (13.2) | 45.4 (10.7) | 44.7 (14.1) | 46.3 (10.7) | 47.7 (12.3) | 44.7 (10.7) |
Gender (women), n (%) | 77 (88.5) | 78 (78.9) | 37 (86.1) | 35 (81.4) | 40 (90.9) | 43 (76.8) |
Race, n (%) | ||||||
White | 65 (75) | 71 (72) | 28 (65) | 27 (63) | 37 (84) | 44 (79) |
Asian | 15 (17) | 20 (20) | 9 (21) | 12 (28) | 6 (14) | 8 (14) |
American Indian or Alaska Native | 1 (1) | 0 (0) | 1 (2) | 0 (0) | 0 (0) | 0 (0) |
Not reported | 6 (7) | 8 (8) | 5 (12) | 4 (9) | 1 (2) | 4 (7) |
BMI (kg/m2), mean (SD) | 25.5 (6.0) | 24.6 (5.0) | 25.7 (5.9) | 24.3 (5.3) | 25.4 (6.1) | 24.8 (4.8) |
Total number of individual preventive medications that failed in the past 10 years, mean (SD) | 4.6 (1.9) | 4.5 (1.8) | 5.3 (2.3) | 4.9 (1.9) | 3.9 (1.0) | 4.2 (1.7) |
Presence of aura at baseline, % (n/N) | 46.0 (40/87) | 42.4 (42/99) | 46.5 (20/43) | 48.8 (21/43) | 45.5 (20/44) | 37.5 (21/56) |
Disease characteristics | ||||||
Time since initial migraine diagnosis, years, mean (SD) | 23.4 (15.8) | 22.4 (13.6) | 24.2 (16.9) | 24.8 (14.2) | 22.6 (14.8) | 20.5 (13.0) |
Number of monthly migraine headache days, mean (SD) | 14.1 (6.1) | 14.0 (5.6) | 18.8 (4.9) | 18.8 (4.6) | 9.5 (2.7) | 10.2 (2.6) |
Number of monthly migraine attacks, mean (SD) | 6.0 (2.0) | 6.0 (1.9) | 6.3 (2.2) | 6.0 (2.3) | 5.7 (1.9) | 6.0 (1.6) |
Number of monthly headache days, mean (SD) | 15.7 (6.1) | 15.7 (6.2) | 20.6 (4.4) | 21.4 (4.7) | 10.8 (2.4) | 11.3 (2.5) |
Number of monthly days with any acute headache medication use at baseline, mean (SD) | 13.0 (6.1) | 13.1 (5.9) | 16.7 (6.0) | 16.7 (6.9) | 9.3 (3.4) | 10.4 (3.0) |
Migraine-Specific Quality of Life Questionnaire—Role Function-Restrictive domain score at baseline, mean (SD) | 42.8 (19.6) | 44.7 (17.4) | 36.7 (18.3) | 40.1 (19.5) | 48.6 (19.3) | 48.3 (14.9) |
Migraine Disability Assessment total score at baseline, mean (SD) | 57.5 (54.8) | 52.0 (49.5) | 81.2 (64.9) | 66.5 (61.0) | 34.4 (28.0) | 41.0 (35.1) |
Acute medication overuse, n (%) | 39 (44.8) | 60 (60.6) | 30 (69.8) | 33 (76.7) | 9 (20.5) | 27 (48.2) |