three doses of lasmiditan (50 mg, 100 mg and 200 mg) compared to placebo in the acute treatment of migraine

Conditions: Migraine With or Without Aura

Summary: 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.

Eligibility criteria:
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.