Assessing Atogepant for Treating Pediatric Migraines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rehabilitation & Neurological Services /ID# 248517
  Huntsville, Alabama, United States Recruiting
• The Center for Clinical Trials - Saraland /ID# 271604
  Saraland, Alabama, United States Recruiting
• Preferred Research Partners /ID# 249729
  Little Rock, Arkansas, United States Recruiting
• Advanced Research Center /ID# 251381
  Anaheim, California, United States Recruiting
• Alliance for Research Alliance for Wellness /ID# 248521
  Long Beach, California, United States Recruiting
• Lumos Clinical Research Center /ID# 249731
  San Jose, California, United States Recruiting

+48 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.