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Study identifier: NCT05711394 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Episodic Migraine  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants450
Who can joinAll sexes, 6 Years to 17 Years
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (98)

Rehabilitation & Neurological Services /ID# 248517Huntsville, Alabama, United StatesRecruiting
The Center for Clinical Trials - Saraland /ID# 271604Saraland, Alabama, United StatesRecruiting
Preferred Research Partners /ID# 249729Little Rock, Arkansas, United StatesRecruiting
Preferred Research Partners /ID# 270406Little Rock, Arkansas, United StatesCompleted
Advanced Research Center /ID# 251381Anaheim, California, United StatesRecruiting
Alliance for Research Alliance for Wellness /ID# 248521Long Beach, California, United StatesRecruiting
Excell Research, Inc /ID# 247532Oceanside, California, United StatesRecruiting
Lumos Clinical Research Center /ID# 249731San Jose, California, United StatesRecruiting
Sunwise Clinical Research /ID# 248529Walnut Creek, California, United StatesRecruiting
Advanced Neurosciences Research, LLC /ID# 247592Fort Collins, Colorado, United StatesCompleted
Northwest Florida Clinical Research Group, LLC /ID# 251382Gulf Breeze, Florida, United StatesRecruiting
Advanced Research Institute of Miami /ID# 248539Homestead, Florida, United StatesCompleted

+ 86 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05711394