A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

Study Overview
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Brief Summary
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This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

Official Title
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RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study

Conditions
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Migraine

Intervention / Treatment
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* Drug: Lasmiditan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2. History of disabling migraine for at least 1 year. Migraine Disability Assessment Test (MIDAS) score ≥11. Migraine onset before the age of 50 years. History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months. Exclusion Criteria: Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets. History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures. History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders. History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy). History of orthostatic hypotension with syncope.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 milligram (mg) Lasmiditan<br>50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Experimental: 100 mg Lasmiditan<br>100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Experimental: 200 mg Lasmiditan<br>200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) | Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose. | 2 Hours Postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Are Headache Pain Free in Each Dose Group | Percentage of participants who are headache pain free in each dose group at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants With Headache Pain Relief | Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine | Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as nonresponder. | 2 Hours Postdose | 
| Percentage of Participants With 24-Hour Sustained Pain Freedom | Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication. | 24 Hours Postdose | 
| Percentage of Participants With 48-Hour Sustained Pain Freedom | Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication. | 48 Hours Postdose | 
| Percentage of Participants That Are Free of Phonophobia | Percentage of participants that are free of phonophobia at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants That Are Free of Photophobia | Percentage of participants that are free of photophobia at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants That Are Free of Nausea | Percentage of participants that are free of nausea at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants That Are Free of Vomiting | Percentage of participants that are free of vomiting at 2 hours postdose. | 2 Hours Postdose | 
| Percentage of Participants With Pain Freedom | Percentage of participants with pain freedom. | 1 Hour Postdose | 
| Percentage of Participants With Headache Pain Relief | Percentage of participants with headache pain relief at 1 hour postdose. | 1 Hour Postdose | 
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) | Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose. | 1 Hour Postdose | 
| Percentage of Participants With No Disability | Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose. | 1 Hour Postdose | 
| Percentage of Participants With No Disability | Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 2 hours postdose. | 2 Hours Postdose | 
| Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan | The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility. | Baseline, 24 Hours Postdose | 
| Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale | The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine). | Baseline, 24 Hours Postdose | 
| Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) | The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants who are responders defined as having rated their impression of change as very much better or much better at 2 hours postdose. | 2 Hours Postdose | 
| Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) | The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug. | 24 Hours Postdose |