A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

• Status: Recruiting
• Trial end date: 2024-11-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Lasmiditan

Criteria

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