Table 3.
Efficacy Endpoints 2 Hours After Single Dose by Treatment Group for Difficult‐to‐Treat Migraine Attacks (ITT Population)
| Lasmiditan 50 mg | Lasmiditan 100 mg | Lasmiditan 200 mg | Placebo | |
|---|---|---|---|---|
| Headache pain‐freedom † , % | ||||
| Time to dosing from migraine headache onset | ||||
| <1 hour (rapidly escalating attacks) | n = 96 | n = 165 | n = 185 | n = 117 |
| 32.9 | 33.2 | 37.1 | 22.2 | |
| OR = 1.48 (1.03, 2.14) | OR = 1.74 (1.32, 2.30) | OR = 2.07 (1.57, 2.73) | ||
| P = .035 | P < .001 | P < .001 | ||
| ≥2 hours | n = 36 | n = 103 | n = 120 | n = 52 |
| 21.7 | 27.6 | 35.0 | 15.6 | |
| OR = 1.26 (0.73, 2.18) | OR = 2.06 (1.42, 2.99) | OR = 2.92 (2.02, 4.24) | ||
| P = .406 | P < .001 | P < .001 | ||
| ≥4 hours | n = 10 | n = 28 | n = 24 | n = 11 |
| 24.4 | 27.5 | 32.4 | 15.9 | |
| OR = 1.13 (0.39, 3.26) | OR = 1.92 (0.88, 4.19) | OR = 2.67 (1.17, 6.07) | ||
| P = .824 | P = .097 | P = .018 | ||
| Severe headache | n = 45 | n = 85 | n = 96 | n = 58 |
| 27.3 | 26.2 | 29.4 | 17.5 | |
| OR = 1.14 (0.70, 1.86) | OR = 1.67 (1.14, 2.43) | OR = 2.03 (1.39, 2.96) | ||
| P = .592 | P = .008 | P < .001 | ||
| Co‐existence of nausea | n = 54 | n = 122 | n = 159 | n = 86 |
| 20.8 | 25.3 | 32.8 | 17.1 | |
| OR = .88 (0.58, 1.33) | OR = 1.65 (1.21, 2.25) | OR = 2.45 (1.81, 3.32) | ||
| P = .534 | P = .001 | P < .001 | ||
| Migraine‐related functional disability (“needs complete bed rest”) | n = 20 | n = 46 | n = 49 | n = 39 |
| 20.2 | 22.6 | 25.9 | 18.5 | |
| OR = .74 (0.38, 1.44) | OR = 1.20 (0.74, 1.94) | OR = 1.56 (0.96, 2.53) | ||
| P = .376 | P = .467 | P = .070 | ||
| MBS‐freedom ‡ , % | ||||
| Time to dosing from migraine headache onset | ||||
| <1 hour (rapidly escalating attacks) | n = 117 | n = 212 | n = 193 | n = 161 |
| 44.2 | 45.2 | 43.1 | 32.9 | |
| OR = 1.40 (0.99, 1.99) | OR = 1.69 (1.30, 2.20) | OR = 1.55 (1.19, 2.03) | ||
| P = .059 | P < .001 | P = .001 | ||
| ≥2 hours | n = 54 | n = 146 | n = 143 | n = 102 |
| 34.8 | 42.7 | 43.9 | 31.9 | |
| OR = 1.11 (0.69, 1.78) | OR = 1.59 (1.16, 2.19) | OR = 1.67 (1.21, 2.30) | ||
| P = .660 | P = .004 | P = .002 | ||
| ≥4 hours | n = 14 | n = 41 | n = 27 | n = 22 |
| 37.8 | 44.6 | 38.0 | 32.8 | |
| OR = 1.17 (0.45, 3.06) | OR = 1.60 (0.83, 3.10) | OR = 1.26 (0.62, 2.53) | ||
| P = .755 | P = .162 | P = .526 | ||
| Severe headache | n = 62 | n = 118 | n = 122 | n = 94 |
| 39.2 | 38.7 | 39.0 | 29.8 | |
| OR = 1.17 (0.74, 1.84) | OR = 1.47 (1.05, 2.06) | OR = 1.53 (1.10, 2.15) | ||
| P = .499 | P = .024 | P = .012 | ||
| Co‐existence of nausea | n = 93 | n = 198 | n = 204 | n = 167 |
| 35.8 | 41.0 | 42.1 | 33.1 | |
| OR = .92 (0.65, 1.32) | OR = 1.41 (1.09, 1.83) | OR = 1.49 (1.15, 1.93) | ||
| P = .664 | P = .010 | P = .003 | ||
| Migraine‐related functional disability (“needs complete bed rest”) | n = 32 | n = 68 | n = 64 | n = 67 |
| 34.0 | 34.2 | 35.2 | 32.7 | |
| OR = .76 (0.42, 1.38) | OR = 1.01 (0.66, 1.53) | OR = 1.12 (0.73, 1.73) | ||
| P = .367 | P = .978 | P = .595 | ||
CI = confidence interval; ITT = intent‐to‐treat; MBS = most bothersome symptom; OR = odds ratio (95% CI).
*
All OR and P values vs placebo.
†
Defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0).
‡
Defined as the absence of the associated symptom of migraine that was identified pre‐dose as the MBS (either nausea, phonophobia, or photophobia).