Biopharmaceutical company CoLucid Pharmaceuticals has begun randomising patients in a second Phase lll trial of lasmiditan, SPARTAN study, to treat acute migraine in adults.
According to the American Migraine Foundation, migraine is a major cause of disability among neurological disorders in the US.
Lasmiditan is designed to be effective in the acute treatment of migraine headaches in adults without the vasoconstrictor activity associated with previous generations of migraine therapies.
It selectively aims 5-HT1F receptors expressed in the trigeminal pathway.
The SPARTAN trial will evaluate the safety and efficacy of lasmiditan, including 50mg, 100mg and 200mg, in comparison to placebo two hours after dosing on freedom from migraine headache pain, which is the primary endpoint, and on freedom from the associated symptoms of a migraine such as nausea, phonophobia or photophobia, the key secondary endpoint.
SPARTAN is a randomised, double-blind, placebo-controlled parallel group study that expects to treat a single migraine in up to 2,226 migraine patients with lasmiditan.
The study will be conducted at around 140 sites in the US, the UK and Germany.
CoLucid anticipates 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).
The trial has been granted a Special Protocol Assessment (SPA) agreement with the US Food and Drug Agency (FDA).
Results from SPARTAN are expected by next year.
CoLucid Pharmaceuticals president and CEO Thomas Mathers said: "We have worked closely with the Division of Neurology Products at FDA to design SPARTAN in a way that we can conduct the trial under SPA agreement.
"A key differentiator between SPARTAN and our ongoing pivotal Phase lll clinical trial SAMURAI is that in SPARTAN, we will study a third and lower dose of 50mg for the acute treatment of migraine.
"The purpose of adding a lower dose is to establish the lowest effective dose of lasmiditan. The 50mg dose may be particularly effective in lower weight or elderly patients."
The company is currently enrolling patients for SAMURAI, the first of two Phase lll clinical trials conducted by CoLucid.
CoLucid is additionally enrolling patients for GLADIATOR, a Phase lll, long-term, open-label trial of lasmiditan.