Using Atogepant tablets to prevent migraines in teens aged 12 to 17
Official title: 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
Run by AbbVie · NCT06810505 · Data updated 2026-11-12
This study is testing if Atogepant tablets can help prevent migraines in teenagers aged 12 to 17.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 66 sites (Huntsville, Alabama and 65 other locations) |
| Status | Recruiting |
| Started | February 13, 2025 |
| Main results expected | March 2031 |
| Study ends | March 2031 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT06810505 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adolescents aged 12 to 17 with a history of chronic migraines for at least 6 months.
✕Probably not a fit
Patients with significant hypertension or other serious health conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness and safety of Atogepant, an oral medication, in preventing chronic migraines in adolescents aged 12 to 17 years. Participants will be randomly assigned to receive either Atogepant or a placebo, with neither the participants nor the researchers knowing which treatment is being administered (double-blind). The study aims to assess adverse events and changes in disease activity over the treatment period. It is designed to provide insights into how well Atogepant can reduce the frequency of migraine attacks in this age group.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency and severity of migraines in adolescents, improving their quality of life.
How similar studies have gone: Previous studies have shown positive results with Atogepant in adult populations, suggesting potential for success in younger patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of chronic 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 as of Visit 1. * During the last 28 days of the screening/baseline period, and as per eDiary: * Participant must have completed the eDiary for a minimum of 20 out of 28 days. * Participant has \>= 15 headache days. * Participant has \>= 8 migraine days. Exclusion Criteria: * Clinically significant hypertension per investigator's judgment. * History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Where it's running
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Rehabilitation and Neurological Services /ID# 270782
Huntsville, Alabama, United States Recruiting -
Preferred Research Partners /ID# 270389
Little Rock, Arkansas, United States Recruiting -
Advanced Research Center /ID# 270257
Anaheim, California, United States Recruiting -
Neuro Pain Research Center /ID# 271048
Fresno, California, United States Recruiting -
Alliance for Research Alliance for Wellness /ID# 270398
Long Beach, California, United States Recruiting -
Excell Research /ID# 270258
Oceanside, California, United States Recruiting
Show 44 more locations
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Lumos Clinical Research Center /ID# 270582
San Jose, California, United States Recruiting -
Sunwise Clinical Research /ID# 270431
Walnut Creek, California, United States Recruiting -
Northwest Florida Clinical Research Group, LLC /ID# 270833
Gulf Breeze, Florida, United States Recruiting -
My Preferred Research /ID# 270312
Miami, Florida, United States Recruiting -
Encore Medical Research - Weston /ID# 271139
Weston, Florida, United States Recruiting -
Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
Winter Park, Florida, United States Recruiting -
Deaconess Midtown Hospital /ID# 270572
Evansville, Indiana, United States Recruiting -
Michigan Headache & Neurological Institute /ID# 270942
Ann Arbor, Michigan, United States Recruiting -
Proven Endpoints LLC /ID# 270269
Ridgeland, Mississippi, United States Recruiting -
Cct Research - Papillion Research Center /ID# 270393
Papillion, Nebraska, United States Recruiting -
Healthy Perspectives - Innovate Mental Health Services /ID# 270847
Nashua, New Hampshire, United States Recruiting -
Dent Neurologic Institute - Amherst /ID# 270260
Amherst, New York, United States Recruiting -
The Children's Hospital of Philadelphia /ID# 270842
Philadelphia, Pennsylvania, United States Recruiting -
Frontier Clinical Research - Scottdale /ID# 270854
Scottdale, Pennsylvania, United States Recruiting -
Frontier Clinical Research - Smithfield /ID# 270849
Smithfield, Pennsylvania, United States Recruiting -
Access Clinical Trials Inc /ID# 270280
Nashville, Tennessee, United States Recruiting -
UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577
Austin, Texas, United States Recruiting -
Earle Research /ID# 270424
Houston, Texas, United States Recruiting -
Clinpoint Trials /ID# 270261
Waxahachie, Texas, United States Recruiting -
Pantheon Clinical Research /ID# 270259
Bountiful, Utah, United States Recruiting -
Alpine Research Organization - Clinton /ID# 276527
Clinton, Utah, United States Recruiting -
Highland Clinical Research /ID# 270281
Salt Lake City, Utah, United States Recruiting -
Frontier Clinical Research - Kingwood /ID# 271053
Kingwood, West Virginia, United States Recruiting -
London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
London, Ontario, Canada Recruiting -
Herlev Hospital /ID# 270482
Herlev, Capital Region, Denmark Recruiting -
Regionshospitalet Godstrup /ID# 270481
Herning, Central Jutland, Denmark Recruiting -
Semmelweis Egyetem /ID# 271219
Budapest, Hungary Recruiting -
Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500
Budapest, Hungary Recruiting -
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
Milan, Milano, Italy Recruiting -
Ospedale Pediatrico Bambino Gesu /ID# 270759
Rome, Roma, Italy Recruiting -
Konan Medical Center /ID# 270486
Kobe, Hyōgo, Japan Recruiting -
Umenotsuji Clinic /ID# 270484
Kochi, Kochi, Japan Recruiting -
Tominaga Clinic - Osaka /ID# 270483
Osaka, Osaka, Japan Recruiting -
Tokyo Headache Clinic /ID# 271610
Shibuya-ku, Tokyo, Japan Recruiting -
Tokyo Medical University Hospital /ID# 270487
Shinjuku-ku, Tokyo, Japan Recruiting -
Tendo Brain Clinic /ID# 271410
Tendo-shi, Yamagata, Japan Recruiting -
Nagaseki Headache Clinic /ID# 271699
Kai, Yamanashi, Japan Recruiting -
Tanaka Neurosurgery & Headache Clinic /ID# 271346
Kagoshima, Japan Recruiting -
Canisius-Wilhelmina Ziekenhuis /ID# 270374
Nijmegen, Gelderland, Netherlands Recruiting -
HagaZiekenhuis /ID# 270379
The Hague, South Holland, Netherlands Recruiting -
Clinical Research Center Medic-R /ID# 270235
Poznan, Greater Poland Voivodeship, Poland Recruiting -
Athleticomed Sp. z o.o /ID# 270243
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland Recruiting -
Specjalistyczne Gabinety Sp. z o.o /ID# 270238
Krakow, Lesser Poland Voivodeship, Poland Recruiting -
MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
Wroclaw, Lower Silesian Voivodeship, Poland Recruiting
+16 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nebulized dexmedetomidine for early chronic migraine
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-
i-NEED: New migraine drugs database
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-
Suppressive Functions of Regulatory T Cells in Migraine
This study tests whether regulatory T cells can help control migraine-related inflammation in adults with chronic migraine.
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Comparing sphenopalatine block and BOTOX for chronic migraine relief
This study is testing whether a nerve block or BOTOX injections can help people with chronic migraines feel better.
-
Acceptance and Commitment Therapy to reduce disability in adults with chronic migraine
This trial will test whether adding Acceptance and Commitment Therapy (ACT) to usual care helps adults with chronic migraine improve daily functioning and reduce headache frequency and pain.
-
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This study tests whether nerve block injections or Botox can help adults with chronic migraines feel better and have fewer migraine days.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.