A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
- Conditions
- Migraine
- Registration Number
- NCT04396236
- 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:<br><br> - Participants must have a history of migraine with or without aura as defined by<br> International Headache Society International Classification of Headache Disorders,<br> 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the<br> following criteria:<br><br> - History of migraine attacks for more than 6 months<br><br> - Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per<br> month in the 2 months prior to screening visit<br><br> - Duration of a typical untreated migraine attack (excluding sleep) is greater<br> than or equal to 3 hours<br><br> - Participant has not, by history, experienced satisfactory response with a<br> previous migraine therapy, in the opinion of the investigator<br><br> - Participant must be able to swallow a tablet<br><br> - For participants taking migraine preventive medication, treatment regimen is stable<br> and has been taken for at least 3 months prior to screening<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
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Pain Freedom (High Dose)
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Pain Freedom (Mid Dose);Percentage of Participants with Pain Freedom (Low Dose);Percentage of Participants with Pain Freedom (Age Sub-Groups);Percentage of Participants with Pain Relief;Percentage of Participants Most Bothersome Symptom (MBS)-Free;Percentage of Participants Nausea-Free;Percentage of Participants Photophobia-Free;Percentage of Participants Phonophobia-Free;Percentage of Participants with Sustained Pain Freedom;Percentage of Participants with Sustained Pain Freedom;Percentage of Participants Using Additional Medication for Migraine;Percentage of Participants Using Additional Medication for Migraine;Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 (Not at All), 1 (a Little), 2 (a Lot), or 3 (Completely);Acceptability of the Formulation: Percentage of Participants with a Rating of Very Easy, Easy, Neither Easy nor Hard, Hard, or Very Hard