A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
- Registration Number
- NCT04396574
- Lead Sponsor
- Eli Lilly and Company
- 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 last about 12 months and may include up to 7 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lasmiditan Dose 1 Lasmiditan Lasmiditan administered orally. Lasmiditan Dose 2 Lasmiditan Lasmiditan administered orally.
- Primary Outcome Measures
Name Time Method Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack Baseline through 12 Months Percentage of TEAEs by Treated Migraine Attack
Percentage of Participants with Discontinuations Due to Adverse Events (AEs) Baseline through 12 Months Percentage of Participants with Discontinuations Due to AEs
- Secondary Outcome Measures
Name Time Method Percentage of Treated Attacks with Pain Freedom at 2 Hours 12 Months Percentage of Treated Attacks with Pain Freedom at 2 Hours
Percentage of Treated Attacks with Pain Relief at 2 Hours 12 Months Percentage of Treated Attacks with Pain Relief at 2 Hours
Percentage of Treated Attacks with MBS Freedom at 2 Hours 12 Months Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours
Trial Locations
- Locations (130)
Central Research Associates
🇺🇸Birmingham, Alabama, United States
Rehabilitation & Neurological Services
🇺🇸Huntsville, Alabama, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Arkansas Children's
🇺🇸Little Rock, Arkansas, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Sensa Health
🇺🇸Los Angeles, California, United States
Orange County Research Institute - Ontario
🇺🇸Ontario, California, United States
Scroll for more (120 remaining)Central Research Associates🇺🇸Birmingham, Alabama, United States