Status:
RECRUITING
A 12-Month 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 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will la...
Eligibility Criteria
Inclusion
- Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
- 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 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04396574
Start Date
June 30 2020
End Date
January 1 2028
Last Update
October 9 2025
Active Locations (133)
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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