This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
3,005
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Time frame: 2 hours post dose
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
Time frame: 2 hours post dose
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Two placebo tablets to match lasmiditan doses.
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc. - ARC
Huntsville, Alabama, United States
21st Century Neurology
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
The Research Center of Southern California
Carlsbad, California, United States
eStudySite
Chula Vista, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute, Newport Beach
Newport Beach, California, United States
Pacific Research Partners
Oakland, California, United States
Desert Valley Research
Rancho Mirage, California, United States
...and 85 more locations