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Lasmiditan treatment for children with migraine

Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

Phase 3 Interventional Eli Lilly and Company · NCT04396236

This study is testing if a new migraine treatment called lasmiditan can help children aged 6 to 17 who have not found relief from other migraine medicines.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1633 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations151 sites (Birmingham, Alabama and 150 other locations)
Trial IDNCT04396236 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of lasmiditan in treating migraines in children aged 6 to 17. It involves administering lasmiditan or a placebo over a period of up to 20 weeks, with participants attending up to four visits. Eligible participants must have a history of migraine attacks and have not responded satisfactorily to previous migraine therapies. The study aims to determine if lasmiditan can provide relief for this age group suffering from moderate-to-severe migraines.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 with a history of moderate-to-severe migraines who have not found relief with previous treatments.

Not a fit: Patients who do not have a history of migraines or have not experienced satisfactory responses to previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing migraines in children.

How similar studies have performed: Other studies have shown promise in treating migraines with similar approaches, but this specific application in children is novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Birmingham, Alabama and 150 other locations

+101 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Migraineacute
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.