🏛️ Verified NIH Record • Updated 2026-08-25

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 (NCT05711394)

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.

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: AbbVie

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Rehabilitation & Neurological Services /ID# 248517 — Huntsville, Alabama

Age range: 6 Years to 17 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (98 Sites)

Showing the first 25 of 98 sites.

  • Rehabilitation & Neurological Services /ID# 248517 — Huntsville, Alabama
  • The Center for Clinical Trials - Saraland /ID# 271604 — Saraland, Alabama
  • Preferred Research Partners /ID# 249729 — Little Rock, Arkansas
  • Preferred Research Partners /ID# 270406 — Little Rock, Arkansas
  • Advanced Research Center /ID# 251381 — Anaheim, California
  • Alliance for Research Alliance for Wellness /ID# 248521 — Long Beach, California
  • Excell Research, Inc /ID# 247532 — Oceanside, California
  • Lumos Clinical Research Center /ID# 249731 — San Jose, California
  • Sunwise Clinical Research /ID# 248529 — Walnut Creek, California
  • Advanced Neurosciences Research, LLC /ID# 247592 — Fort Collins, Colorado
  • Northwest Florida Clinical Research Group, LLC /ID# 251382 — Gulf Breeze, Florida
  • Advanced Research Institute of Miami /ID# 248539 — Homestead, Florida
  • My Preferred Research LLC /ID# 249720 — Miami, Florida
  • FWD Clinical Research - Spring Hill /ID# 248525 — Spring Hill, Florida
  • Coastal Georgia Child Neurology /ID# 249733 — Brunswick, Georgia
  • Deaconess Clinic - Gateway Health Center /ID# 247589 — Newburgh, Indiana
  • College Park Family Care Center Overland Park /ID# 249734 — Overland Park, Kansas
  • Michigan Headache & Neurological Institute (MHNI) /ID# 247468 — Ann Arbor, Michigan
  • Proven Endpoints LLC /ID# 258066 — Ridgeland, Mississippi
  • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536 — Papillion, Nebraska
  • Goryeb Childrens Hospital /ID# 249724 — Morristown, New Jersey
  • Dent Neurologic Institute - Amherst /ID# 248534 — Amherst, New York
  • Modern Migraine MD /ID# 258074 — New York, New York
  • Headache Wellness Center /ID# 251018 — Greensboro, North Carolina
  • Patient Priority Clinical Sites, LLC /ID# 247535 — Cincinnati, Ohio

📞 Contact the Study Coordinator

Phone: (844) 663-3742

Email: abbvieclinicaltrials@abbvie.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Episodic Migraine

Explore by condition: All Episodic Migraine clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗