A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Study Overview
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Brief Summary
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The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

Official Title
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Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

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 must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: History of migraine attacks for more than 6 months Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator Participant must be able to swallow a tablet For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening Participants must weigh at least 15 kilograms (kg) Exclusion Criteria: Participants must not be pregnant or nursing Participants must not have any acute, serious, or unstable medical condition Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 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: Lasmiditan High Dose<br>Lasmiditan administered orally with matching placebo to maintain the blind. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Experimental: Lasmiditan Mid Dose<br>Lasmiditan administered orally with matching placebo to maintain the blind. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Experimental: Lasmiditan Low Dose<br>Lasmiditan administered orally with matching placebo to maintain the blind. | Drug: Lasmiditan<br>* Administered orally<br>* Other names: LY573144;Drug: Placebo<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo administered orally. | 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 with Pain Freedom (High Dose) | Percentage of Participants with Pain Freedom (High Dose) | 2 Hours Postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Pain Freedom (Mid Dose) | Percentage of Participants with Pain Freedom (Mid Dose) | 2 Hours Postdose | 
| Percentage of Participants with Pain Freedom (Low Dose) | Percentage of Participants with Pain Freedom (Low Dose) | 2 Hours Postdose | 
| Percentage of Participants with Pain Freedom (Age Sub-Groups) | Percentage of Participants with Pain Freedom (Age Sub-Groups) | 2 Hours Postdose | 
| Percentage of Participants with Pain Relief | Percentage of Participants with Pain Relief | 2 Hours Postdose | 
| Percentage of Participants Most Bothersome Symptom (MBS)-Free | Percentage of Participants MBS-Free | 2 Hours Postdose | 
| Percentage of Participants Nausea-Free | Percentage of Participants Nausea-Free | 2 Hours Postdose | 
| Percentage of Participants Photophobia-Free | Percentage of Participants Photophobia-Free | 2 Hours Postdose | 
| Percentage of Participants Phonophobia-Free | Percentage of Participants Phonophobia-Free | 2 Hours Postdose | 
| Percentage of Participants with Sustained Pain Freedom | Percentage of Participants with Sustained Pain Freedom | 24 Hours Postdose | 
| Percentage of Participants with Sustained Pain Freedom | Percentage of Participants with Sustained Pain Freedom | 48 Hours Postdose | 
| Percentage of Participants Using Additional Medication for Migraine | Percentage of Participants Using Additional Medication for Migraine | 24 Hours Postdose | 
| Percentage of Participants Using Additional Medication for Migraine | Percentage of Participants Using Additional Medication for Migraine | 48 Hours Postdose | 
| Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 (Not at All), 1 (a Little), 2 (a Lot), or 3 (Completely) | Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 (Not at All), 1 (a Little), 2 (a Lot), or 3 (Completely) | 2 Hours Postdose | 
| Acceptability of the Formulation: Percentage of Participants with a Rating of Very Easy, Easy, Neither Easy nor Hard, Hard, or Very Hard | Acceptability of the Formulation: Percentage of Participants with a Rating of Very Easy, Easy, Neither Easy nor Hard, Hard, or Very Hard | 24 Hours Postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute