Status:
RECRUITING
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1633 Patients enrolled
Trial Details
Trial ID
NCT04396236
Start Date
June 15 2020
End Date
November 1 2026
Last Update
October 9 2025
Active Locations (150)
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1
Central Research Associates
Birmingham, Alabama, United States, 35205
2
Rehabilitation & Neurological Services
Huntsville, Alabama, United States, 35805
3
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
4
Perseverance Research Center
Scottsdale, Arizona, United States, 85254