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

September 1, 2026 updated by: AbbVie

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Completed
        • McGill University Health Centre - Glen Site /ID# 270662
  • Denmark
    • Capital Region
      • Herlev, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev Hospital /ID# 270482
    • Central Jutland
      • Herning, Central Jutland, Denmark, 7400
        • Recruiting
        • Regionshospitalet Godstrup /ID# 270481
  • Hungary
      • Budapest, Hungary, 1085
        • Recruiting
        • Semmelweis Egyetem /ID# 271219
      • Budapest, Hungary, 1141
        • Recruiting
        • Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500
  • Italy
    • Milano
      • Milan, Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756
    • Roma
      • Rome, Roma, Italy, 00165
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu /ID# 270759
  • Japan
      • Kagoshima, Japan, 890-0052
        • Recruiting
        • Tanaka Neurosurgery & Headache Clinic /ID# 271346
    • Hyōgo
      • Kobe, Hyōgo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center /ID# 270486
    • Kochi
      • Kochi, Kochi, Japan, 780-8011
        • Recruiting
        • Umenotsuji Clinic /ID# 270484
    • Osaka
      • Osaka, Osaka, Japan, 556-0015
        • Recruiting
        • Tominaga Clinic - Osaka /ID# 270483
        • Contact:
          • Site Coordinator
          • Phone Number: ＋81-6-6643-2660
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Recruiting
        • Tokyo Headache Clinic /ID# 271610
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 270487
    • Yamagata
      • Tendo-shi, Yamagata, Japan, 994-0083
        • Recruiting
        • Tendo Brain Clinic /ID# 271410
    • Yamanashi
      • Kai, Yamanashi, Japan, 400-0124
        • Recruiting
        • Nagaseki Headache Clinic /ID# 271699
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6532 SZ
        • Recruiting
        • Canisius-Wilhelmina Ziekenhuis /ID# 270374
    • South Holland
      • The Hague, South Holland, Netherlands, 2545 AA
        • Recruiting
        • HagaZiekenhuis /ID# 270379
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-848
        • Recruiting
        • Clinical Research Center Medic-R /ID# 270235
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
        • Recruiting
        • Athleticomed Sp. z o.o /ID# 270243
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-539
        • Recruiting
        • Specjalistyczne Gabinety Sp. z o.o /ID# 270238
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny /ID# 270239
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 01-018
        • Recruiting
        • Oha-Med Sp. Z O.O /ID# 270242
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Unidade Local de Saude de Coimbra /ID# 277993
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Unidade Local de Saude de Santa Maria /ID# 277997
      • Porto, Portugal, 4099-003
        • Recruiting
        • Unidade Local de Saude de Santo Antonio /ID# 278090
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1500-650
        • Recruiting
        • Hospital da Luz /ID# 277991
    • Setúbal District
      • Almada, Setúbal District, Portugal, 2805-267
        • Recruiting
        • Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092
        • Contact:
          • Site Coordinator
          • Phone Number: 351 21 294 0294
  • Puerto Rico
      • San Juan, Puerto Rico, 00918-3501
        • Completed
        • Caribbean Medical Research Center Headlands /ID# 271300
  • United Kingdom
      • Stockport, United Kingdom, SK2 7JE
        • Recruiting
        • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
    • Greater London
      • London, Greater London, United Kingdom, WC1N 3HZ
        • Recruiting
        • Great Ormond Street Children's Hospital /ID# 271550
    • Kent
      • Gillingham, Kent, United Kingdom, ME7 5NY
        • Recruiting
        • Medway Maritime Hospital /ID# 271885
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZG
        • Recruiting
        • Royal Aberdeen Children's Hospital /ID# 271664
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Recruiting
        • Rehabilitation and Neurological Services /ID# 270782
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Completed
        • Preferred Research Partners - Fayetteville /ID# 270419
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners /ID# 270389
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center /ID# 270257
      • Fresno, California, United States, 93710
        • Recruiting
        • Neuro Pain Research Center /ID# 271048
      • Long Beach, California, United States, 90807
        • Recruiting
        • Accellacare - Long Beach /ID# 270398
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research /ID# 270258
      • San Jose, California, United States, 95124
        • Recruiting
        • Lumos Clinical Research Center /ID# 270582
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Sunwise Clinical Research /ID# 270431
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Recruiting
        • Northwest Florida Clinical Research Group, LLC /ID# 270833
      • Lakeland, Florida, United States, 33813
        • Completed
        • Auzmer Research /ID# 271158
      • Miami, Florida, United States, 33155
        • Recruiting
        • My Preferred Research /ID# 270312
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research - Weston /ID# 271139
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Recruiting
        • Deaconess Midtown Hospital /ID# 270572
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Recruiting
        • Michigan Headache & Neurological Institute /ID# 270942
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • Proven Endpoints LLC /ID# 270269
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Recruiting
        • Cct Research - Papillion Research Center /ID# 270393
    • New Hampshire
      • Nashua, New Hampshire, United States, 03060
        • Recruiting
        • Healthy Perspectives - Innovate Mental Health Services /ID# 270847
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute - Amherst /ID# 270260
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Completed
        • Headache Wellness Center /ID# 270568
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Recruiting
        • Frontier Clinical Research - Scottdale /ID# 270854
      • Smithfield, Pennsylvania, United States, 15478
        • Recruiting
        • Frontier Clinical Research - Smithfield /ID# 270849
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Access Clinical Trials Inc /ID# 270280
    • Texas
      • Austin, Texas, United States, 78723-3079
        • Recruiting
        • UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577
      • Houston, Texas, United States, 77058
        • Recruiting
        • Earle Research /ID# 270424
      • Waxahachie, Texas, United States, 75165
        • Recruiting
        • Clinpoint Trials /ID# 270261
    • Utah
      • Bountiful, Utah, United States, 84010
        • Recruiting
        • Pantheon Clinical Research /ID# 270259
      • Clinton, Utah, United States, 84015
        • Recruiting
        • Alpine Research Organization - Clinton /ID# 276527
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Highland Clinical Research /ID# 270281
    • West Virginia
      • Kingwood, West Virginia, United States, 26537
        • Recruiting
        • Frontier Clinical Research - Kingwood /ID# 271053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atogepant
Participants will receive atogepant once daily for 12 weeks.
Drug: Atogepant
Oral tablet
Other Names:
  • Qulipta
  • Aquipta
Placebo Comparator: Placebo for Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks.
Drug: Placebo for Atogepant
Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 16 weeks
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.
Up to approximately 16 weeks
Change From Baseline in Mean Monthly Migraine Days
Time Frame: Baseline (Week 0) through Week 12
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Baseline (Week 0) through Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Monthly Headache Days
Time Frame: Baseline (Week 0) through Week 12
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.
Baseline (Week 0) through Week 12
Change From Baseline in Mean Monthly Acute Medication Use Days
Time Frame: Baseline (Week 0) through Week 12
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.
Baseline (Week 0) through Week 12
Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days
Time Frame: Baseline (Week 0) through Week 12
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.
Baseline (Week 0) through Week 12
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score
Time Frame: Baseline (Week 0) through Week 12
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.
Baseline (Week 0) through Week 12
Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score
Time Frame: Baseline (Week 0) through Week 12
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.
Baseline (Week 0) through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M23-712
  • 2024-513836-28 (EU CT)
  • 2024-513836-28-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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