A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Episodic Migraine

In brief

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Key facts

Study ID: NCT05711394
Run by: AbbVie
People needed: 450
Starts: 2023-05-01
Expected to finish: 2028-05-01
Last updated by the study team: 2026-07-14

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Children's Hospital of Philadelphia - Main /ID# 258071 — Philadelphia, Pennsylvania, United States (enrolling)
UT Health Austin at Dell Children's Neurology Clinic /ID# 264082 — Austin, Texas, United States (enrolling)
Cincinnati Childrens Hospital Medical Center /ID# 258070 — Cincinnati, Ohio, United States (enrolling)
Lynn Institute of Oklahoma City /ID# 247600 — Oklahoma City, Oklahoma, United States (enrolling)
Preferred Research Partners /ID# 249729 — Little Rock, Arkansas, United States (enrolling)
Access Clinical Trials, Inc. /ID# 248532 — Nashville, Tennessee, United States (enrolling)
The Center for Clinical Trials - Saraland /ID# 271604 — Saraland, Alabama, United States (enrolling)
Sunwise Clinical Research /ID# 248529 — Walnut Creek, California, United States (enrolling)
Advanced Research Center /ID# 251381 — Anaheim, California, United States (enrolling)
Rehabilitation & Neurological Services /ID# 248517 — Huntsville, Alabama, United States (enrolling)
Alliance for Research Alliance for Wellness /ID# 248521 — Long Beach, California, United States (enrolling)
My Preferred Research LLC /ID# 249720 — Miami, Florida, United States (enrolling)
Excell Research, Inc /ID# 247532 — Oceanside, California, United States (enrolling)
Coastal Georgia Child Neurology /ID# 249733 — Brunswick, Georgia, United States (enrolling)
Deaconess Clinic - Gateway Health Center /ID# 247589 — Newburgh, Indiana, United States (enrolling)
Lumos Clinical Research Center /ID# 249731 — San Jose, California, United States (enrolling)
Michigan Headache & Neurological Institute (MHNI) /ID# 247468 — Ann Arbor, Michigan, United States (enrolling)
Proven Endpoints LLC /ID# 258066 — Ridgeland, Mississippi, United States (enrolling)
Cognitive Clinical Trials (CCT) - Papillion /ID# 248536 — Papillion, Nebraska, United States (enrolling)
Goryeb Childrens Hospital /ID# 249724 — Morristown, New Jersey, United States (enrolling)
Dent Neurologic Institute - Amherst /ID# 248534 — Amherst, New York, United States (enrolling)
Northwest Florida Clinical Research Group, LLC /ID# 251382 — Gulf Breeze, Florida, United States (enrolling)
Headache Wellness Center /ID# 251018 — Greensboro, North Carolina, United States (enrolling)
Patient Priority Clinical Sites, LLC /ID# 247535 — Cincinnati, Ohio, United States (enrolling)
FutureSearch Trials of Neurology /ID# 247470 — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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