Enrolling

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

H8H-MC-LAHV -

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine.

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See if You May Qualify

Answer a few questions to see if you meet key criteria for this study.

Trial Summary

Age Range
6 - 17 years
Conditions the trial is for
Migraine
What the trial is testing?
lasmiditan (LY-573144)
Could I receive a Placebo?
Yes
Enrollment Goal
1633
Trial Dates
Jun 15, 2020 - Jan 2025
How long will I be in the trial?
The study will last up to 20 weeks and may include up to 4 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • 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:

  • 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

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Clinical Trial Resources

Pain Research

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Clinical Trial Information

A clinical trial helps us learn if a new potential medicine or treatment works and how it works. Clinical trials are also called clinical research studies. To learn more about what to expect when taking part in a clinical trial, visit our Clinical Trial Information page.