Migraine
Conditions
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion 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 greater than or equal to 11. -Migraine onset before the age of 50 years. -History of 3-8 migraine attacks per month and less than 15 headache days per month during the past 3 months.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Percentage of Participants who are Pain Free (High Dose) [ Time Frame: 2 Hours Postdose ] | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Percentage of Participants who are Pain Free in Each Dose Group [ Time Frame: 2 Hours Postdose ] -Percentage of Participants with Pain Relief [ Time Frame: 2 Hours Postdose ] | — |
Countries
Japan
Outcome results
None listed