CoLucid Pharmaceuticals Provides SPARTAN Enrollment Update

  • Comparison of 50 mg, 100 mg and 200 mg of lasmiditan oral tablets to placebo for the acute treatment of migraine
  • Over 50% of the expected 2,968 migraine patients enrolled
  • 77% of patients enrolled to date have multiple cardiovascular risk factors, similar to SAMURAI
  • Primary and key secondary endpoints, and their powering, the same as SAMURAI
  • Data expected in the second half of 2017

CAMBRIDGE, Mass., Nov. 14, 2016 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today announced that over 50% of the 2,968 migraine patients expected to enroll in the Company's SPARTAN trial, the second of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SPARTAN is to evaluate the safety and efficacy of lasmiditan (50 mg, 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 key secondary endpoint.

SPARTAN is a randomized, double-blind, placebo-controlled parallel group study.  The study is expected to treat a single migraine in up to 2,226 migraine patients with lasmiditan at approximately 140 sites in the United States, United Kingdom and Germany.  CoLucid expects that migraine patients enrolled in SPARTAN will include those who also have one or more cardiovascular risk factors, stable cardiovascular disease or known coronary artery disease ("CAD"). Both the primary and key secondary endpoints, and their statistical powering, of SPARTAN are the same as SAMURAI, CoLucid's recently completed first Phase 3 pivotal clinical trial. SPARTAN is being conducted under a Special Protocol Assessment ("SPA") agreement with the U.S. Food and Drug Administration ("FDA"). Top-line results from SPARTAN are expected in the second half of 2017.

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