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

Investigating Migraine Treatment Options in Children and Adolescents

A
Andrea Haller

Primary Investigator

Enrolling By Invitation
6 years - 17 years
All
Phase N/A
2 participants needed
1 Location

Brief description of study

Study LAHV will assess the efficacy, safety, and tolerability of lasmiditan 50 mg, 100 mg, and 200 mg compared to placebo in the treatment of a single migraine attack in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

 
  • Patients will treat a single migraine attack in 2 stages: a double-blind placebo challenge (Stage 1) prior to randomization in the efficacy analysis period (Stage 2).
  • Patients will record characteristics of treated migraine and outcomes in an electronic diary prior to dosing and at specified intervals after dosing. Patients will record any AEs and concomitant use of medication throughout the Treatment Period in a paper diary.
  • An End-of-Study Visit will be conducted within 28 days of dosing of study medication or after 12 weeks if no migraine attack is treated with study drug

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Migraine
  • Age: 6 years - 17 years
  • Gender: All

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

Updated on 10 Jul 2025. Study ID: FWNC-LILLY-PIONEER-PEDS, 23948

This study investigates the effectiveness, safety, and tolerability of an investigational medication for treating acute migraine attacks in children and adolescents aged 6 to 17. The purpose is to compare different doses of the investigational medication to a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. A migraine is a type of headache that can cause severe pain, often accompanied by nausea, vomiting, and sensitivity to light or sound.

Participants will treat a single migraine attack in two stages. In the first stage, they will undergo a placebo challenge before moving to the second stage, where they will be randomly assigned to receive either the investigational medication or a placebo. Participants will document their migraine symptoms and any side effects in electronic and paper diaries throughout the study.

  • Who can participate: Children and adolescents aged 6 to 17 with a history of migraine for more than 6 months can participate. They must have 2 to 8 moderate-to-severe migraine attacks per month and be able to swallow a tablet. Participants should weigh at least 15 kg and have a stable preventive medication regimen if applicable.
  • Study details: Participants will treat a single migraine attack in two stages: an initial placebo challenge followed by randomization to receive either the investigational medication or placebo.
  • Study timelines and visits: The study will last 20 weeks. The study requires 4 visits.
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only