CoLucid Pharmaceuticals Announces Initiation of First Phase 3 Pivotal Trial of Lasmiditan in Migraine
First Patient Randomized in SAMURAI STUDY Trial Being Conducted Under Special Protocol Assessment Agreement with FDA
BURLINGTON, Mass., April 28, 2015 – CoLucid Pharmaceuticals, Inc., a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that the first patient has been randomized in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan.
The objective of SAMURAI is to evaluate the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is our primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is our secondary endpoint. SAMURAI is a randomized, double-blind, placebo-controlled parallel group study. The study is expected to treat up to 1,483 migraine patients with lasmiditan at approximately 70 U.S. sites for approximately 12 months. We expect patients will include those with migraine who also have cardiovascular risk factors or cardiovascular disease. SAMURAI is being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration.
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