Phase 2 randomized placebo‐controlled study of lasmiditan for the acute treatment of migraine in Japanese patients
Headache: The Journal of Head and Face Pain May 28, 2021
Sakai F, Takeshima T, Homma G, et al. - Researchers conducted this multicenter, randomized, double‐blind, placebo‐controlled, phase 2 study to test the safety and effectiveness of lasmiditan, the first of a new class of antimigraine therapeutics known as ditans, in Japanese adults with migraine. Adults with migraine with or without aura were randomized 7:3:7:6 to placebo, lasmiditan 50 mg, 100 mg, or 200 mg to be self‐administered orally within 4 h of onset of a single moderate‐to‐severe migraine attack. In total, 863 candidates were screened, and 846 (98.0%) candidates were randomized. The majority of treatment-emergent adverse events were mild and of short duration, with dizziness, somnolence, and malaise being the most common in all lasmiditan groups, and no serious adverse events were reported. Overall, the authors concluded that lasmiditan was well tolerated and effective for the acute treatment of migraine in Japanese patients, which was consistent with global phase 3 studies.
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