Completion status | Total number of lasmiditan doses | Totalb | ||||
---|---|---|---|---|---|---|
Lasmiditan dosing summarya | Completed n = 321 | Discontinued due to AE n = 22 | Discontinued due to lack of efficacy n = 36 | < 10 n = 156 | ≥ 10 n = 289 | N = 445 |
Total number of lasmiditan doses administered | 24.0 (17.45) | 6.2 (7.26) | 8.0 (7.30) | 4.3 (2.51) | 27.7 (15.93) | 19.5 (17.09) |
Lasmiditan doses per month | 1.8 (1.34) | 1.4 (0.80) | 1.6 (1.04) | 0.7 (0.56) | 2.2 (1.24) | 1.7 (1.28) |
Last dose in double-blind period, n (%)c | ||||||
Placebo | 53 (80.3) | 5 (7.6) | 8 (12.1) | 40 (50.0) | 40 (50.0) | 80 (100) |
50 | 61 (80.3) | 6 (7.9) | 9 (11.8) | 30 (34.5) | 57 (65.5) | 87 (100) |
100 | 106 (85.5) | 5 (4.0) | 13 (10.5) | 47 (32.2) | 99 (67.8) | 146 (100) |
200 | 101 (89.4) | 6 (5.3) | 6 (5.3) | 39 (29.5) | 93 (70.5) | 132 (100) |
Modal dose, n (%)d | ||||||
50 mg | 52 (16.2) | 0 (0) | 3 (8.3) | 11 (7.1) | 46 (15.9) | 57 (12.8) |
100 mg | 205 (63.9) | 18 (81.8) | 20 (55.6) | 114 (73.1) | 179 (61.9) | 293 (65.8) |
200 mg | 64 (19.9) | 4 (18.2) | 13 (36.1) | 30 (19.2) | 64 (22.1) | 94 (21.1) |
Completion status | Lasmiditan doses | Totalb | ||||
Demographics and clinical characteristicsa | Completed n = 321 | Discontinued due to AE n = 22 | Discontinued due to lack of efficacy n = 36 | < 10 n = 156 | ≥ 10 n = 289 | N = 445 |
Age, years | 43.0 (12.0) | 38.7 (10.3) | 45.1 (9.9) | 40.2 (11.8) | 43.8 (11.7) | 42.5 (11.9) |
Sex, female, n (%) | 271 (84.4) | 19 (86.4) | 33 (91.7) | 136 (87.2) | 247 (85.5) | 383 (86.1) |
MIDAS Total Score | ||||||
Baseline (V1) | 28.4 (17.73) | 34.4 (34.67) | 39.5 (33.32) | 25.5 (12.72) | 29.1 (18.73) | 28.4 (17.73) |
Last Visit (V11 EoS) | 15.3 (21.64) | NA | NA | 7.9 (9.18) | 17.2 (23.41) | 15.3 (21.64) |
MIDAS Headache Days | ||||||
Baseline (V1) | 16.5 (9.92) | 20.5 (8.53) | 18.9 (8.75) | 15.4 (7.97) | 16.8 (10.34) | 16.5 (9.92) |
Last Visit (V11 EoS) | 10.6 (11.90) | NA | NA | 6.6 (9.01) | 11.6 (12.34) | 10.6 (11.90) |
MIDAS Average Pain Severity | ||||||
Baseline (V1) | 7.5 (1.67) | 7.5 (1.62) | 7.3 (1.40) | 7.3 (1.73) | 7.5 (1.65) | 7.5 (1.67) |
Last Visit (V11 EoS) | 6.2 (2.17) | NA | NA | 5.2 (2.72) | 6.4 (1.95) | 6.2 (2.17) |
MSQ Total Score | ||||||
OLE baseline (V6) | 61.9 (16.31) | 59.1 (18.47) | 58.3 (17.71) | 64.6 (15.86) | 61.2 (16.39) | 61.9 (16.31) |
Last Visit (V11 EoS or ET)e | 73.2 (18.10) | 66.9 (14.76) | 58.8 (19.68) | 81.7 (17.65) | 70.9 (17.58) | 73.2 (18.10) |
MSQ Role Function Restrictive | ||||||
OLE baseline (V6) | 55.3 (16.91) | 52.9 (19.13) | 50.6 (18.80) | 57.8 (16.02) | 54.6 (17.10) | 55.3 (16.91) |
Last Visit (V11 EoS or ET)e | 68.0 (19.65) | 59.7 (15.12) | 52.2 (18.24) | 77.8 (20.28) | 65.5 (18.70) | 68.0 (19.65) |
MSQ Role Function Preventive | ||||||
OLE baseline (V6) | 69.1 (19.21) | 66.8 (20.08) | 65.6 (18.39) | 71.4 (19.64) | 68.5 (19.09) | 69.1 (19.21) |
Last Visit (V11 EoS or ET)e | 78.7 (17.89) | 76.3 (13.83) | 66.5 (23.05) | 86.2 (15.18) | 76.8 (18.06) | 78.7 (17.89) |
MSQ Emotional Function | ||||||
OLE baseline (V6) | 68.1 (23.01) | 63.2 (27.34) | 66.5 (20.69) | 71.6 (22.21) | 67.2 (23.16) | 68.1 (23.01) |
Last Visit (V11 EoS or ET)e | 77.9 (21.37) | 71.2 (25.73) | 63.7 (24.45) | 84.8 (20.36) | 76.2 (21.3) | 77.9 (21.37) |
mTOQ-6 Baselinef (V2) | 4.5 (2.54) | 5.0 (2.45) | 4.0 (2.89) | 4.6 (2.47) | 4.6 (2.59) | 4.6 (2.55) |
PGIC-MHC, n (%) (V11 EoS) | ||||||
Very much better | 46 (14.3) | 1 (4.6) | 0 | 15 (9.6) | 35 (12.1) | 50 (11.2) |
Much better | 77 (24.0) | 0 | 0 | 18 (11.5) | 65 (22.5) | 83 (18.7) |
A little better | 83 (25.9) | 3 (13.6) | 1 (2.8) | 23 (14.7) | 69 (23.9) | 92 (20.7) |
No change | 98 (30.5) | 13 (59.1) | 26 (72.2) | 62 (39.7) | 95 (32.9) | 157 (35.3) |
A little worse | 10 (3.1) | 3 (13.6) | 4 (11.1) | 11 (7.1) | 9 (3.1) | 20 (4.5) |
Much worse | 3 (0.9) | 0 | 1 (2.8) | 0 | 4 (1.4) | 4 (0.9) |
Very much worse | 1 (0.3) | 0 | 0 | 0 | 1 (0.4) | 1 (0.2) |