An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine

Study Overview
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Brief Summary
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This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.

Official Title
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An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Lasmiditan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA). Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.) 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 all migraine attacks treated with study drug. Exclusion Criteria: Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study. Pregnant or breast-feeding women. Women of child-bearing potential not using or not willing to use highly effective contraception. Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS). Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174). Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lasmiditan 100mg<br>Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. | Drug: Lasmiditan<br>* oral tablet<br>* Other names: LY573144;|
| Experimental: Lasmiditan 200mg<br>Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose. | Drug: Lasmiditan<br>* oral tablet<br>* Other names: LY573144;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With at Least 1 Treatment Emergent Adverse Event | An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose | Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0). | Up to 12 months | 
| Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose | MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom. | Up to 12 months |