Phase 2 randomized placebo-controlled study of lasmiditan for the acute treatment of migraine in Japanese patients.

ABSTRACT:

Objective

To evaluate the efficacy and safety of lasmiditan in Japanese adults with migraine.

Background

Global clinical studies have demonstrated the efficacy and safety of lasmiditan in the acute treatment of migraine.

Methods

This was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study in Japan (NCT03962738), which enrolled adults with migraine with or without aura. Participants 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. Participants recorded their response to treatment prior to dosing and for 48 h postdose. The primary endpoint was headache pain freedom at 2 h postdose.

Results

Participants (N = 846) were ran

SUBMITTER: Sakai F 

PROVIDER: S-EPMC8252620 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature