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Assessing Atogepant for Treating Pediatric Migraines

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

Phase 3 Interventional AbbVie · NCT05711394

This study is testing if Atogepant tablets can help children aged 6 to 17 with migraines feel better by reducing how often and how badly their headaches happen.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorAbbVie Industry-sponsored
Locations98 sites (Huntsville, Alabama and 97 other locations)
Trial IDNCT05711394 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of oral Atogepant tablets in children aged 6 to 17 who experience episodic migraines. Participants will be randomly assigned to receive either a low or high dose of Atogepant or a placebo, with the aim of determining how well the medication works in reducing migraine frequency and severity. The study includes a pharmacokinetic substudy for younger participants aged 6 to 11. The trial is designed to provide insights into a treatment option that is currently limited for pediatric patients.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 6 to 17 with a history of episodic migraines, experiencing 4 to 14 migraine days per month.

Not a fit: Patients with chronic migraines or specific types of migraines such as hemiplegic or retinal migraines may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from episodic migraines.

How similar studies have performed: Other studies have shown promise in treating migraines in adults with similar medications, but this approach in pediatric populations is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
* History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
* Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
* To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria:

* History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
* Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
* Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Where this trial is running

Huntsville, Alabama and 97 other locations

+48 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 Episodic MigraineAtogepantQULIPTAAGN-241689
Last reviewed 2026-06-15 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.