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

• Status: Completed
• Trial end date: 2020-06-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Lasmiditan

Criteria

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.