CoLucid Pharmaceuticals announces initiation of first Phase 3 pivotal trial of lasmiditan in migraine

CoLucid Pharmaceuticals has announced that the first patient has been randomised in its SAMURAI study, the Company’s first Phase 3 pivotal trial of lasmiditan.

Lasmiditan has been designed to deliver efficacy for the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies.

SAMURAI lasmiditan trial being conducted under a Special Protocol Assessment with the FDA

 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 the primary endpoint, and on freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia), which is the secondary endpoint.  SAMURAI is a randomised, 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 around 12 months.  CoLucid 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.

CoLucid has successfully completed seven clinical studies for lasmiditan, including a thorough QTc study and a Phase 2b study evaluating lasmiditan as a treatment for a single migraine attack in 391 patients. Lasmiditan is designed to address major unmet medical needs in patients who are poorly served by currently available therapies, including patients with cardiovascular risk factors or cardiovascular disease who may not be able to take triptans.