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

Study Overview
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Brief Summary
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This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Detailed Description
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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.

Official Title
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A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

Conditions
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Migraine With or Without Aura

Intervention / Treatment
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* Drug: Lasmiditan 50 mg
* Drug: Lasmiditan 100 mg
* Drug: Lasmiditan 200 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasmiditan 50 milligram (mg)<br>Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. | Drug: Lasmiditan 50 mg<br>* One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)<br>* Other names: LY573144;|
| Experimental: Lasmiditan 100 mg<br>Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. | Drug: Lasmiditan 100 mg<br>* One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)<br>* Other names: LY573144;|
| Experimental: Lasmiditan 200 mg<br>Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. | Drug: Lasmiditan 200 mg<br>* One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)<br>* Other names: LY573144;|
| Placebo Comparator: Placebo<br>Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours. | Drug: Placebo<br>* Two placebo tablets to match lasmiditan doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 hours post dose |