Treatment in Children Aged 6 to 17 With Migraine.
- Conditions
- Health Condition 1: G431- Migraine with aura
- Registration Number
- CTRI/2020/11/029312
- 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
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)
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 Percentage of Participants with Pain FreedomTimepoint: 2 Hours Postdose
- Secondary Outcome Measures
Name Time Method