A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years (NCT06810505)
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
🩺 Plain-English Summary (8th-Grade Level)
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Who can join: Review the eligibility criteria below.
Location: Rehabilitation and Neurological Services /ID# 270782 — Huntsville, Alabama
Age range: 12 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (64 Sites)
Showing the first 25 of 64 sites.
- Rehabilitation and Neurological Services /ID# 270782 — Huntsville, Alabama
- Preferred Research Partners - Fayetteville /ID# 270419 — Fayetteville, Arkansas
- Preferred Research Partners /ID# 270389 — Little Rock, Arkansas
- Advanced Research Center /ID# 270257 — Anaheim, California
- Neuro Pain Research Center /ID# 271048 — Fresno, California
- Accellacare - Long Beach /ID# 270398 — Long Beach, California
- Excell Research /ID# 270258 — Oceanside, California
- Lumos Clinical Research Center /ID# 270582 — San Jose, California
- Sunwise Clinical Research /ID# 270431 — Walnut Creek, California
- Northwest Florida Clinical Research Group, LLC /ID# 270833 — Gulf Breeze, Florida
- Auzmer Research /ID# 271158 — Lakeland, Florida
- My Preferred Research /ID# 270312 — Miami, Florida
- Encore Medical Research - Weston /ID# 271139 — Weston, Florida
- Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 — Winter Park, Florida
- Deaconess Midtown Hospital /ID# 270572 — Evansville, Indiana
- Michigan Headache & Neurological Institute /ID# 270942 — Ann Arbor, Michigan
- Proven Endpoints LLC /ID# 270269 — Ridgeland, Mississippi
- Cct Research - Papillion Research Center /ID# 270393 — Papillion, Nebraska
- Healthy Perspectives - Innovate Mental Health Services /ID# 270847 — Nashua, New Hampshire
- Dent Neurologic Institute - Amherst /ID# 270260 — Amherst, New York
- Headache Wellness Center /ID# 270568 — Greensboro, North Carolina
- Frontier Clinical Research - Scottdale /ID# 270854 — Scottdale, Pennsylvania
- Frontier Clinical Research - Smithfield /ID# 270849 — Smithfield, Pennsylvania
- Access Clinical Trials Inc /ID# 270280 — Nashville, Tennessee
- UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577 — Austin, Texas
📞 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 Chronic Migraine
- A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults — Birmingham, Alabama
- A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine — Huntsville, Alabama
- Effects of Online Mindfulness Therapy on Pain and Stress in Adults With Chronic Migraine and Adverse Childhood Experiences — Bucaramanga, Santander Department
- Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial — Vancouver, British Columbia
- BOTOX® vs. XEOMIN® for Chronic Migraine — Jacksonville, North Carolina
- Cannabis for the Prophylactic Treatment of Migraine — Calgary, Alberta
Explore by condition: All Chronic Migraine clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.