A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Phase 3
Recruiting
- Conditions
- Migraine
- Registration Number
- NCT04396574
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Inclusion Criteria:<br><br> - Participants must have completed study H8H-MC-LAHX (NCT03988088) or study<br> H8H-MC-LAHV (NCT number to be determined)<br><br> - Participants must weigh at least 15 kilograms (kg)<br><br>Exclusion Criteria:<br><br> - Participants must not be pregnant or nursing<br><br> - Participants must not have any acute, serious, or unstable medical condition<br><br> - Participants must not be actively suicidal or at significant risk for suicide, in<br> the opinion of the investigator
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack;Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Percentage of Treated Attacks with Pain Freedom at 2 Hours;Percentage of Treated Attacks with Pain Relief at 2 Hours;Percentage of Treated Attacks with MBS Freedom at 2 Hours