Treatment of migraine in children aged 6 to 17
Phase 3
- Conditions
- Health Condition 1: G431- Migraine with aura
- Registration Number
- CTRI/2020/12/029700
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack <br/ ><br>2. Percentage of Participants with Discontinuations Due to Adverse Events (AEs)Timepoint: Baseline through 12 Months
- Secondary Outcome Measures
Name Time Method 1. Percentage of Treated Attacks with Pain Freedom at 2 Hours <br/ ><br>2. Percentage of Treated Attacks with Pain Relief at 2 Hours <br/ ><br>3. Percentage of Treated Attacks with MBS Freedom at 2 HoursTimepoint: 12 Months