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Chronic MigrainePhase 3NCT06810505

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

A Phase 3 study testing Atogepant in people with Chronic Migraine, run by AbbVie at 66 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Chronic Migraine
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
66 sitesin 11 countries
Study dates
13 Feb 2025to Mar 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Clinically significant hypertension per investigator's judgment.
  • History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Trial locations and contacts

66 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

66 sites in 11 countries

United States32 sites, 29 recruiting

  • Dent Neurologic Institute - Amherst /ID# 270260

    Amherst, New York, 14226

    Recruiting

  • Advanced Research Center /ID# 270257

    Anaheim, California, 92805

    Recruiting

  • Michigan Headache & Neurological Institute /ID# 270942

    Ann Arbor, Michigan, 48104

    Recruiting

  • UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577

    Austin, Texas, 78723-3079

    Recruiting

  • Pantheon Clinical Research /ID# 270259

    Bountiful, Utah, 84010

    Recruiting

  • Alpine Research Organization - Clinton /ID# 276527

    Clinton, Utah, 84015

    Recruiting

  • Deaconess Midtown Hospital /ID# 270572

    Evansville, Indiana, 47710

    Recruiting

  • Preferred Research Partners - Fayetteville /ID# 270419

    Fayetteville, Arkansas, 72703

    Completed

  • Neuro Pain Research Center /ID# 271048

    Fresno, California, 93710

    Recruiting

  • Headache Wellness Center /ID# 270568

    Greensboro, North Carolina, 27405

    Completed

  • Northwest Florida Clinical Research Group, LLC /ID# 270833

    Gulf Breeze, Florida, 32561

    Recruiting

  • Earle Research /ID# 270424

    Houston, Texas, 77058

    Recruiting

  • Rehabilitation and Neurological Services /ID# 270782

    Huntsville, Alabama, 35805

    Recruiting

  • Frontier Clinical Research - Kingwood /ID# 271053

    Kingwood, West Virginia, 26537

    Recruiting

  • Auzmer Research /ID# 271158

    Lakeland, Florida, 33813

    Completed

  • Preferred Research Partners /ID# 270389

    Little Rock, Arkansas, 72211

    Recruiting

  • Alliance for Research Alliance for Wellness /ID# 270398

    Long Beach, California, 90807

    Recruiting

  • My Preferred Research /ID# 270312

    Miami, Florida, 33155

    Recruiting

  • Healthy Perspectives - Innovate Mental Health Services /ID# 270847

    Nashua, New Hampshire, 03060

    Recruiting

  • Access Clinical Trials Inc /ID# 270280

    Nashville, Tennessee, 37203

    Recruiting

  • Excell Research /ID# 270258

    Oceanside, California, 92056

    Recruiting

  • Cct Research - Papillion Research Center /ID# 270393

    Papillion, Nebraska, 68046

    Recruiting

  • The Children's Hospital of Philadelphia /ID# 270842

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Proven Endpoints LLC /ID# 270269

    Ridgeland, Mississippi, 39157

    Recruiting

  • Highland Clinical Research /ID# 270281

    Salt Lake City, Utah, 84124

    Recruiting

  • Lumos Clinical Research Center /ID# 270582

    San Jose, California, 95124

    Recruiting

  • Frontier Clinical Research - Scottdale /ID# 270854

    Scottdale, Pennsylvania, 15683

    Recruiting

  • Frontier Clinical Research - Smithfield /ID# 270849

    Smithfield, Pennsylvania, 15478

    Recruiting

  • Sunwise Clinical Research /ID# 270431

    Walnut Creek, California, 94596

    Recruiting

  • Clinpoint Trials /ID# 270261

    Waxahachie, Texas, 75165

    Recruiting

  • Encore Medical Research - Weston /ID# 271139

    Weston, Florida, 33331

    Recruiting

  • Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

Japan8 sites, 8 recruiting

  • Tanaka Neurosurgery & Headache Clinic /ID# 271346

    Kagoshima, 890-0052

    Recruiting

  • Nagaseki Headache Clinic /ID# 271699

    Kai, Yamanashi, 400-0124

    Recruiting

  • Konan Medical Center /ID# 270486

    Kobe, Hyōgo, 658-0064

    Recruiting

  • Umenotsuji Clinic /ID# 270484

    Kochi, Kochi, 780-8011

    Recruiting

  • Tominaga Clinic - Osaka /ID# 270483

    Osaka, Osaka, 556-0015

    Site Coordinator, ＋81-6-6643-2660

    Recruiting

  • Tokyo Headache Clinic /ID# 271610

    Shibuya-ku, Tokyo, 151-0051

    Recruiting

  • Tokyo Medical University Hospital /ID# 270487

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

  • Tendo Brain Clinic /ID# 271410

    Tendo-shi, Yamagata, 994-0083

    Recruiting

Other trials in Japan

Poland5 sites, 5 recruiting

  • Athleticomed Sp. z o.o /ID# 270243

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

    Recruiting

  • Specjalistyczne Gabinety Sp. z o.o /ID# 270238

    Krakow, Lesser Poland Voivodeship, 30-539

    Recruiting

  • Clinical Research Center Medic-R /ID# 270235

    Poznan, Greater Poland Voivodeship, 60-848

    Recruiting

  • Oha-Med Sp. Z O.O /ID# 270242

    Warsaw, Masovian Voivodeship, 01-018

    Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny /ID# 270239

    Wroclaw, Lower Silesian Voivodeship, 52-210

    Recruiting

Other trials in Poland

Portugal5 sites, 5 recruiting

  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092

    Almada, Setúbal District, 2805-267

    Site Coordinator, 351 21 294 0294

    Recruiting

  • Unidade Local de Saude de Coimbra /ID# 277993

    Coimbra, 3000-075

    Recruiting

  • Hospital da Luz /ID# 277991

    Lisbon, Lisbon District, 1500-650

    Recruiting

  • Unidade Local de Saude de Santa Maria /ID# 277997

    Lisbon, 1649-035

    Recruiting

  • Unidade Local de Saude de Santo Antonio /ID# 278090

    Porto, 4099-003

    Recruiting

Other trials in Portugal

United Kingdom5 sites, 5 recruiting

  • Royal Aberdeen Children's Hospital /ID# 271664

    Aberdeen, Scotland, AB25 2ZG

    Recruiting

  • Medway Maritime Hospital /ID# 271885

    Gillingham, Kent, ME7 5NY

    Recruiting

  • Leeds Teaching Hospitals NHS Trust /ID# 273449

    Leeds, West Yorkshire, LS9 7TF

    Recruiting

  • Great Ormond Street Children's Hospital /ID# 271550

    London, Greater London, WC1N 3HZ

    Recruiting

  • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883

    Stockport, SK2 7JE

    Recruiting

Other trials in United Kingdom

Canada2 sites, 1 recruiting

  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659

    London, Ontario, N6A 5W9

    Recruiting

  • McGill University Health Centre - Glen Site /ID# 270662

    Montreal, Quebec, H4A 3J1

    Completed

Other trials in Canada

Denmark2 sites, 2 recruiting

  • Herlev Hospital /ID# 270482

    Herlev, Capital Region, 2730

    Recruiting

  • Regionshospitalet Godstrup /ID# 270481

    Herning, Central Jutland, 7400

    Recruiting

Other trials in Denmark

Hungary2 sites, 2 recruiting

  • Semmelweis Egyetem /ID# 271219

    Budapest, 1085

    Recruiting

  • Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500

    Budapest, 1141

    Recruiting

Other trials in Hungary

Italy2 sites, 2 recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756

    Milan, Milano, 20133

    Recruiting

  • Ospedale Pediatrico Bambino Gesu /ID# 270759

    Rome, Roma, 00165

    Recruiting

Other trials in Italy

Netherlands2 sites, 2 recruiting

  • Canisius-Wilhelmina Ziekenhuis /ID# 270374

    Nijmegen, Gelderland, 6532 SZ

    Recruiting

  • HagaZiekenhuis /ID# 270379

    The Hague, South Holland, 2545 AA

    Recruiting

Other trials in Netherlands

Puerto Rico1 site

  • Caribbean Medical Research Center Headlands /ID# 271300

    San Juan, 00918-3501

    Completed

Other trials in Puerto Rico

About this study

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

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.

Read more

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.

Being tested
Atogepant, Placebo for Atogepant
Keywords
Migraine, Chronic Migraine, Atogepant, QULIPTA, AQUIPTA
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called Qulipta, Aquipta

    Oral tablet

  • Placebo for AtogepantDrug

    Oral tablet

Study groups in NCT06810505
Study groupRoleWhat they receive
AtogepantExperimentalParticipants will receive atogepant once daily for 12 weeks.
Receives: Drug: Atogepant
Placebo for AtogepantPlacebo comparatorParticipants will receive placebo for atogepant once daily for 12 weeks.
Receives: Drug: Placebo for Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Adverse Events (AEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 16 weeks

  2. Change From Baseline in Mean Monthly Migraine Days

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Measured: Baseline (Week 0) through Week 12

Secondary outcomes (5)

  1. Change From Baseline in Mean Monthly Headache Days

    A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) through Week 12

  2. Change From Baseline in Mean Monthly Acute Medication Use Days

    An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.

    Measured: Baseline (Week 0) through Week 12

  3. Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days

    A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.

    Measured: Baseline (Week 0) through Week 12

  4. Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score

    The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.

    Measured: Baseline (Week 0) through Week 12

  5. Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score

    The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.

    Measured: Baseline (Week 0) through Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start13 Feb 2025
  3. Primary completionMar 2031 (estimated)
  4. Study completionMar 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810505
Sponsor's protocol ID
M23-712
Other IDs
2024-513836-28, 2024-513836-28-00
Status last verified
Oct 2026
First submitted
31 Jan 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Publications

  • Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14.

    PubMed 41235617

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Chronic Migraine, run by AbbVie at 66 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Japan, Poland, Portugal, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06810505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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