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

  • STATUS
    Recruiting
  • participants needed
    1646
  • sponsor
    Eli Lilly and Company
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Updated on 19 February 2024
See if I qualify
treatment regimen
headache
lasmiditan
preventive medication
migraine
ly573144

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.

Details
Condition Migraine, migraine (pediatric), Primary Stabbing Headache, migraine (pediatric)
Age 6-17 years
Treatment Placebo, Lasmiditan
Clinical Study IdentifierNCT04396236
SponsorEli Lilly and Company
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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