A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study

This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

Inclusion Criteria:

• Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
• History of disabling migraine for at least 1 year.
• Migraine Disability Assessment Test (MIDAS) score ≥11.
• Migraine onset before the age of 50 years.
• History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.

Exclusion Criteria:

• Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.
• History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.
• History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.
• History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).
• History of orthostatic hypotension with syncope.