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Treatment of migraines in children aged 6 to 17 with lasmiditan

A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2

Phase 3 Interventional Eli Lilly and Company · NCT04396574

This study is testing if a new migraine medication called lasmiditan can help children aged 6 to 17 feel better during migraine attacks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations135 sites (Birmingham, Alabama and 134 other locations)
Trial IDNCT04396574 on ClinicalTrials.gov

What this trial studies

This 12-month open-label study evaluates the safety and effectiveness of lasmiditan for treating acute migraines in children aged 6 to 17. Participants will receive the medication and attend up to 7 visits throughout the study period. The goal is to determine how well lasmiditan works for this age group and to monitor any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 to 17 who have previously participated in specific related studies and weigh at least 15 kg.

Not a fit: Patients who are pregnant, nursing, or have serious medical conditions or significant suicidal risk 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 less explored.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 134 other locations

+85 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 Migraineacutelong-termopen labelsafety
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.