Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

Enrolling by invitation · Phase 3

Conditions studied: Migraine Prophylaxis

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 participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. 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 migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 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

NCT05707949

Run by

AbbVie

People needed

650

Starts

2023-06-05

Expected to finish

2032-04-01

Last updated by the study team

2025-08-11

Who can join

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

You may qualify if…

• Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
• The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
• Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
• A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; 2018) for at least 6 months.

You may not qualify if…

• 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).
• Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Where it is running

• Preferred Research Partners /ID# 250937 — Little Rock, Arkansas, United States
• Advanced Research Center /ID# 251616 — Anaheim, California, United States
• Sunwise Clinical Research /ID# 250913 — Lafayette, California, United States
• Alliance for Research Alliance for Wellness /ID# 250911 — Long Beach, California, United States
• Excell Research, Inc /ID# 251611 — Oceanside, California, United States
• Lumos Clinical Research Center /ID# 251608 — San Jose, California, United States
• Advanced Neurosciences Research, LLC /ID# 250925 — Fort Collins, Colorado, United States
• Northwest Florida Clinical Research Group, LLC /ID# 251614 — Gulf Breeze, Florida, United States
• Advanced Research Institute of Miami /ID# 250916 — Homestead, Florida, United States
• My Preferred Research LLC /ID# 250931 — Miami, Florida, United States
• Asclepes Research Centers - Spring Hill /ID# 250912 — Spring Hill, Florida, United States
• Coastal Georgia Child Neurology /ID# 250938 — Brunswick, Georgia, United States
• Deaconess Clinic - Gateway Health Center /ID# 250923 — Newburgh, Indiana, United States
• College Park Family Care Center Overland Park /ID# 251609 — Overland Park, Kansas, United States
• Michigan Headache & Neurological Institute (MHNI) /ID# 250920 — Ann Arbor, Michigan, United States
• Proven Endpoints LLC /ID# 258083 — Ridgeland, Mississippi, United States
• Cognitive Clinical Trials (CCT) - Papillion /ID# 251610 — Papillion, Nebraska, United States
• Goryeb Children's Hospital /ID# 250934 — Morristown, New Jersey, United States
• Dent Neurosciences Research Center, Inc. /ID# 250915 — Amherst, New York, United States
• Modern Migraine MD /ID# 258082 — New York, New York, United States
• Headache Wellness Center /ID# 251612 — Greensboro, North Carolina, United States
• Patient Priority Clinical Sites, LLC /ID# 250922 — Cincinnati, Ohio, United States
• CincyScience /ID# 250935 — West Chester, Ohio, United States
• Lynn Institute of Oklahoma City /ID# 250926 — Oklahoma City, Oklahoma, United States
• Rehabilitation & Neurological Services /ID# 250910 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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