Lasmiditan dosing summarya | 100 mg (continuous) n = 209 | 50 mg/100 mg n = 90 | 100 mg/200 mg n = 136 | 50 mg/100 mg/ 200 mg n = 6 | Totalb N = 445 |
---|---|---|---|---|---|
Total number of lasmiditan doses administered | 18.7 (18.08) | 19.5 (16.42) | 21.0 (16.28) | 20.3 (8.71) | 19.5 (17.09) |
Lasmiditan doses per month | 1.7 (1.34) | 1.6 (1.22) | 1.8 (1.23) | 1.9 (1.41) | 1.7 (1.28) |
Last dose in double-blind period, n (%)c | |||||
Placebo | 35 (43.8) | 14 (17.5) | 28 (35.0) | 1 (1.3) | 80 (100) |
50 mg | 42 (48.3) | 23 (26.4) | 21 (24.1) | 1 (1.1) | 87 (100) |
100 mg | 66 (45.2) | 28 (19.2) | 50 (34.2) | 2 (1.4) | 146 (100) |
200 mg | 66 (50.0) | 25 (18.9) | 37 (28.0) | 2 (1.5) | 132 (100) |
Modal dosed | |||||
50 mg | 0 | 52 (57.8) | 0 | 3 (50.0) | 57 (12.8) |
100 mg | 209 (100) | 38 (42.2) | 43 (31.6) | 3 (50.0) | 293 (65.8) |
200 mg | 0 | 0 | 93 (68.4) | 0 | 94 (21.1) |
Completed, n (%) | 144 (68.9) | 72 (80.0) | 98 (72.1) | 5 (83.3) | 321 (72.1) |
Demographics and clinical characteristicsa | 100 mg (continuous) n = 209 | 50 mg/100 mg n = 90 | 100 mg/200 mg n = 136 | 50 mg/100 mg/ 200 mg n = 6 | Totalb N = 445 |
Age, years | 41.5 (12.7) | 41.1 (10.9) | 45.3 (11.0) | 42.5 (8.4) | 42.5 (11.9) |
Sex, female, n, (%) | 181 (86.6) | 82 (91.1) | 112 (82.4) | 5 (83.3) | 383 (86.1) |
Body weight, kg | 76.5 (18.1) | 74.9 (18.3) | 81.0 (21.6) | 79.0 (17.3) | 77.5 (19.3) |
Migraine history, years | 16.1 (12.1) | 19.5 (12.5) | 21.2 (13.2) | 14.8 (12.0) | 18.3 (12.7) |
Migraine attacks/month in the 3 months prior to study baseline | 5.0 (1.6) | 5.1 (1.5) | 5.0 (1.5) | 4.8 (1.5) | 5.0 (1.5) |
Migraine, aura status, n (%) | |||||
With aura | 45 (21.5) | 28 (31.1) | 24 (17.6) | 0 (0.0) | 98 (22.0) |
Without aura | 121 (57.9) | 44 (48.9) | 79 (58.1) | 5 (83.3) | 251 (56.4) |
With and without aura | 43 (20.6) | 18 (20.0) | 33 (24.3) | 1 (16.7) | 96 (21.6) |
Use of migraine preventive during study, n (%) | 67 (32.1) | 29 (32.2) | 41 (30.1) | 2 (33.3) | 140 (31.5) |
Triptan experience, n (%) | 133 (63.6) | 64 (71.1) | 97 (71.3) | 6 (100.0) | 302 (67.9) |
MIDAS Total Score | |||||
Baseline (V1) | 25.8 (15.36) | 31.4 (20.73) | 30.4 (18.61) | 18.8 (5.81) | 28.4 (17.73) |
Last visit (V11 EoS) | 12.2 (15.04) | 15.2 (14.88) | 20.3 (31.51) | 12.0 (6.28) | 15.3 (21.64) |
MIDAS Headache Days | |||||
Baseline (V1) | 15.7 (8.36) | 15.8 (10.51) | 18.2 (11.56) | 17.8 (5.45) | 16.5 (9.92) |
Last visit (V11 EoS) | 8.9 (9.40) | 10.3 (10.12) | 13.2 (14.91) | 14.6 (23.92) | 10.6 (11.90) |
MIDAS Average Pain Severity | |||||
Baseline (V1) | 7.7 (1.54) | 7.2 (1.74) | 7.3 (1.74) | 7.0 (2.24) | 7.5 (1.67) |
Last visit (V11 EoS) | 6.1 (2.35) | 6.1 (2.07) | 6.4 (1.89) | 5.6 (3.36) | 6.2 (2.17) |
MSQ Total Score | |||||
OLE baseline (V6) | 60.5 (17.54) | 64.4 (13.58) | 61.4 (16.37) | 70.1 (10.58)) | 61.9 (16.31) |
Last visit (V11 EoS) | 73.2 (18.84) | 75.5 (17.42) | 71.3 (17.62) | 67.1 (11.20) | 73.2 (18.10) |
MSQ Role Function Restrictive | |||||
OLE baseline (V6) | 54.1 (17.70) | 57.6 (14.18) | 54.7 (17.52) | 60.1 (16.60) | 55.3 (16.91) |
Last visit (V11 EoS) | 68.3 (20.61) | 70.6 (18.25) | 65.6 (19.13) | 59.4 (14.48) | 68.0 (19.65) |
MSQ Role Function Preventive | |||||
OLE baseline (V6) | 67.5 (21.29) | 71.6 (15.15) | 68.6 (18.61) | 88.0 (11.51) | 69.1 (19.21) |
Last visit (V11 EoS) | 77.9 (18.75) | 81.5 (16.99) | 77.7 (17.20) | 76.0 (18.84) | 78.7 (17.89) |
MSQ Emotional Function | |||||
OLE baseline (V6) | 66.9 (24.56) | 70.7 (20.97) | 67.4 (22.45) | 69.3 (14.6`) | 68.1 (23.01) |
Last visit (V11 EoS) | 78.4 (21.10) | 79.0 (22.58) | 76.3 (21.45) | 73.3 (9.43) | 77.9 (21.37) |
mTOQ-6 (V2 Baseline)e | 4.8 (2.55) | 4.6 (2.48) | 4.3 (2.57) | 4.8 (2.95) | 4.6 (2.55) |
PGIC-MHC n (%) | |||||
Very much better | 19 (9.1) | 11 (12.2) | 19 (14.0) | 1 (16.7) | 50 (11.2) |
Much better | 53 (25.4) | 11 (12.2) | 19 (14.0) | 0 | 83 (18.7) |
A little better | 46 (22.0) | 25 (27.8) | 20 (14.7) | 1 (16.7) | 92 (20.7) |
No change | 58 (27.8) | 33 (36.7) | 59 (43.4) | 4 (66.7) | 157 (35.3) |
A little worse | 7 (3.4) | 3 (3.3) | 10 (7.4) | 0 | 20 (4.5) |
Much worse | 1 (0.5) | 1 (1.1) | 2 (1.5) | 0 | 4 (0.9) |
Very much worse | 0 | 1 (1.1) | 0 | 0 | 1 (0.2) |