Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

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.

Inclusion criteria

• Able and willing to give written informed consent and authorize HIPAA.
• Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).
• History of disabling migraine for at least 1 year.
• Migraine Disability Association (MIDAS) score ≥11.
• Migraine onset before the age of 50 years.
• History of 3 - 8 migraine attacks per month (< 15 headache days per month).
• Male or female, aged 18 years or above.
• Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
• Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.

Exclusion criteria

• Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
• Pregnant or breast-feeding women.
• Women of child-bearing potential not using or not willing to use highly effective contraception.
• Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
• History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
• History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
• History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
• History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
• History of orthostatic hypotension with syncope.
• Significant renal or hepatic impairment.
• Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
• Previous participation in this clinical trial.
• Participation in any clinical trial of an experimental drug or device in the previous 30 days.
• Known Hepatitis B or C or HIV infection.
• History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
• Use of more than 3 doses per month of either opiates or barbiturates.
• Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
• Participants who are employees of the sponsor.
• Relatives of, or staff directly reporting to, the Investigator.