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.