TerminatedPhase 3

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Stopped: Study terminated due to strategic business decision

United States566 participantsStarted 2020-06-30

Plain-language summary

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Who can participate

Age range6 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack

Timeframe: Baseline through 12 Months

Percentage of Participants with Discontinuations Due to Adverse Events (AEs)

Timeframe: Baseline through 12 Months

Trial details

NCT IDNCT04396574

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-04

View on ClinicalTrials.gov More Migraine trials