A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (NCT04396236) | Clinical Trial Compass
TerminatedPhase 3
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Stopped: Study terminated due to strategic business decision
United States851 participantsStarted 2020-06-15
Plain-language summary
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
Who can participate
Age range6 Years – 17 Years
SexALL
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Inclusion Criteria:
* 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)
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
What they're measuring
1
Percentage of Participants with Pain Freedom (High Dose)