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

Last updated: April 13, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Migraine (Adult)

Migraine And Cluster Headaches

Migraine (Pediatric)

Treatment

Atogepant

Placebo for Atogepant

Clinical Study ID

NCT06810505
M23-712
2024-513836-28-00
2024-513836-28
  • Ages 12-17
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of chronic migraine with or without aura consistent with a diagnosisaccording 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

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 Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: Atogepant
Phase: 3
Study Start date:
February 13, 2025
Estimated Completion Date:
March 31, 2031

Connect with a study center

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

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

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

    London 6058560, Ontario 6093943 N6A 5W9
    Canada

    Site Not Available

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

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

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

    Montreal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Active - Recruiting

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

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Site Not Available

  • Herlev Hospital /ID# 270482

    Herlev, Capital Region 2730
    Denmark

    Active - Recruiting

  • Herlev Hospital /ID# 270482

    Herlev 2620431, Capital Region 6418538 2730
    Denmark

    Site Not Available

  • Regionshospitalet Godstrup /ID# 270481

    Herning, Central Jutland 7400
    Denmark

    Active - Recruiting

  • Regionshospitalet Godstrup /ID# 270481

    Herning 2620425, Central Jutland 6418539 7400
    Denmark

    Site Not Available

  • Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500

    Budapest, 1141
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem /ID# 271219

    Budapest, 1085
    Hungary

    Active - Recruiting

  • Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500

    Budapest 3054643, 1141
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 271219

    Budapest 3054643, 1085
    Hungary

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756

    Milan, Milano 20133
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756

    Milan 3173435, Milano 20133
    Italy

    Site Not Available

  • Ospedale Pediatrico Bambino Gesù /ID# 270759

    Rome, Roma 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù /ID# 270759

    Rome 3169070, Roma 00165
    Italy

    Site Not Available

  • Konan Medical Center /ID# 270486

    Kobe-shi, Hyogo 658-0064
    Japan

    Site Not Available

  • Konan Medical Center /ID# 270486

    Kobe, Hyōgo 658-0064
    Japan

    Active - Recruiting

  • Konan Medical Center /ID# 270486

    Kobe 1859171, Hyōgo 1862047 658-0064
    Japan

    Site Not Available

  • Umenotsuji Clinic /ID# 270484

    Kochi, Kochi 780-8011
    Japan

    Active - Recruiting

  • Umenotsuji Clinic /ID# 270484

    Kochi-shi, Kochi 780-8011
    Japan

    Site Not Available

  • Umenotsuji Clinic /ID# 270484

    Kochi 1859146, Kochi 1859133 780-8011
    Japan

    Site Not Available

  • Tominaga Clinic - Osaka /ID# 270483

    Osaka, Osaka 556-0015
    Japan

    Active - Recruiting

  • Tominaga Clinic /ID# 270483

    Osaka-shi, Osaka 556-0015
    Japan

    Site Not Available

  • Tominaga Clinic - Osaka /ID# 270483

    Osaka 1853909, Osaka 1853904 556-0015
    Japan

    Site Not Available

  • Tokyo Headache Clinic /ID# 271610

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital /ID# 270487

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tendo Brain Clinic /ID# 271410

    Tendo-shi, Yamagata 994-0083
    Japan

    Active - Recruiting

  • Nagaseki Headache Clinic /ID# 271699

    Kai, Yamanashi 400-0124
    Japan

    Active - Recruiting

  • Nagaseki Headache Clinic /ID# 271699

    Kai 11612336, Yamanashi 1848649 400-0124
    Japan

    Site Not Available

  • Tanaka Neurosurgery & Headache Clinic /ID# 271346

    Kagoshima, 890-0052
    Japan

    Active - Recruiting

  • Tanaka Neurosurgery & Headache Clinic /ID# 271346

    Kagoshima 1860827, 890-0052
    Japan

    Site Not Available

  • Canisius-Wilhelmina Ziekenhuis /ID# 270374

    Nijmegen, Gelderland 6532 SZ
    Netherlands

    Active - Recruiting

  • Canisius-Wilhelmina Ziekenhuis /ID# 270374

    Nijmegen 2750053, Gelderland 2755634 6532 SZ
    Netherlands

    Site Not Available

  • HagaZiekenhuis /ID# 270379

    The Hague, South Holland 2545 AA
    Netherlands

    Active - Recruiting

  • HagaZiekenhuis /ID# 270379

    The Hague 2747373, South Holland 2743698 2545 AA
    Netherlands

    Site Not Available

  • HagaZiekenhuis /ID# 270379

    Den Haag, Zuid-Holland 2545 AA
    Netherlands

    Site Not Available

  • Clinical Research Center Medic-R /ID# 270235

    Poznan, Greater Poland Voivodeship 60-848
    Poland

    Active - Recruiting

  • Clinical Research Center Medic-R /ID# 270235

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-848
    Poland

    Site Not Available

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-752
    Poland

    Active - Recruiting

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

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-752
    Poland

    Site Not Available

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

    Krakow, Lesser Poland Voivodeship 30-539
    Poland

    Active - Recruiting

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

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-539
    Poland

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny /ID# 270239

    Wroclaw, Lower Silesian Voivodeship 52-210
    Poland

    Active - Recruiting

  • MIGRE Polskie Centrum Leczenia Migreny /ID# 270239

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 52-210
    Poland

    Site Not Available

  • Oha-Med Sp. Z O.O /ID# 270242

    Warsaw, Masovian Voivodeship 01-018
    Poland

    Active - Recruiting

  • OHA-MED sp. z o.o /ID# 270242

    Warsaw 756135, Masovian Voivodeship 858787 00-414
    Poland

    Site Not Available

  • OHA-MED sp. z o.o /ID# 270242

    Warszawa, Mazowieckie 00-414
    Poland

    Site Not Available

  • Clinical Research Center Sp. z o.o., Medic-R /ID# 270235

    Poznan, Wielkopolskie 61-731
    Poland

    Active - Recruiting

  • Hospital da Luz /ID# 277991

    Lisbon, Lisbon District 1500-650
    Portugal

    Active - Recruiting

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

    Almada, Setúbal District 2805-267
    Portugal

    Active - Recruiting

  • Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 278090

    Porto, 4099-003
    Portugal

    Active - Recruiting

  • CMRC Headlands LLC /ID# 271300

    San Juan, 00918-3501
    Puerto Rico

    Active - Recruiting

  • Caribbean Medical Research Center /ID# 271300

    San Juan, 00918-3501
    Puerto Rico

    Site Not Available

  • CMRC Headlands LLC /ID# 271300

    San Juan 4568127, 00918-3501
    Puerto Rico

    Site Not Available

  • Caribbean Medical Research Center /ID# 271300

    San Juan 4568127, 00918-3501
    Puerto Rico

    Active - Recruiting

  • Stockport NHS Foundation Trust /ID# 271883

    Stockport, Cheshire SK2 7JE
    United Kingdom

    Site Not Available

  • Stockport NHS Foundation Trust /ID# 271883

    Stockport 2636882, Cheshire SK2 7JE
    United Kingdom

    Active - Recruiting

  • Medway Maritime Hospital /ID# 271885

    Gillingham, Kent ME7 5NY
    United Kingdom

    Active - Recruiting

  • Medway Maritime Hospital /ID# 271885

    Gillingham 2648657, Kent ME7 5NY
    United Kingdom

    Site Not Available

  • Royal Aberdeen Children's Hospital /ID# 271664

    Aberdeen, Scotland AB25 2ZG
    United Kingdom

    Active - Recruiting

  • Royal Aberdeen Children's Hospital /ID# 271664

    Aberdeen 2657832, Scotland 2638360 AB25 2ZG
    United Kingdom

    Site Not Available

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

    Stockport, SK2 7JE
    United Kingdom

    Active - Recruiting

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

    Stockport 2636882, SK2 7JE
    United Kingdom

    Site Not Available

  • Rehabilitation & Neurological Services /ID# 270782

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Rehabilitation & Neurological Services /ID# 270782

    Huntsville 4068590, Alabama 4829764 35805
    United States

    Site Not Available

  • Preferred Research Partner, Inc /ID# 270389

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Preferred Research Partners /ID# 270389

    Little Rock, Arkansas 72211
    United States

    Active - Recruiting

  • Preferred Research Partners /ID# 270419

    Little Rock, Arkansas 72211
    United States

    Completed

  • Preferred Research Partner, Inc /ID# 270389

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • Preferred Research Partners /ID# 270389

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Active - Recruiting

  • Preferred Research Partners /ID# 270419

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Completed

  • Advanced Research Center /ID# 270257

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Neuro Pain Medical Center /ID# 271048

    Fresno, California 93710
    United States

    Site Not Available

  • Neuro Pain Research Center /ID# 271048

    Fresno, California 93710
    United States

    Active - Recruiting

  • Accellacare - Long Beach /ID# 270398

    Long Beach, California 90807
    United States

    Active - Recruiting

  • Excell Research /ID# 270258

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Lumos Clinical Research Center /ID# 270582

    San Jose, California 95124
    United States

    Active - Recruiting

  • Sunwise Clinical Research /ID# 270431

    Walnut Creek, California 94596
    United States

    Active - Recruiting

  • Advanced Research Center /ID# 270257

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Neuro Pain Medical Center /ID# 271048

    Fresno 5350937, California 5332921 93710
    United States

    Active - Recruiting

  • Neuro Pain Research Center /ID# 271048

    Fresno 5350937, California 5332921 93710
    United States

    Site Not Available

  • Accellacare - Long Beach /ID# 270398

    Long Beach 5367929, California 5332921 90807
    United States

    Site Not Available

  • Excell Research /ID# 270258

    Oceanside 5378771, California 5332921 92056
    United States

    Site Not Available

  • Lumos Clinical Research Center /ID# 270582

    San Jose 5392171, California 5332921 95124
    United States

    Site Not Available

  • Sunwise Clinical Research /ID# 270431

    Walnut Creek 5406990, California 5332921 94596
    United States

    Site Not Available

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

    Gulf Breeze, Florida 32561
    United States

    Active - Recruiting

  • Auzmer Research /ID# 271158

    Lakeland, Florida 33813
    United States

    Completed

  • My Preferred Research /ID# 270312

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Encore Medical Research - Weston /ID# 271139

    Weston, Florida 33331
    United States

    Active - Recruiting

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

    Winter Park, Florida 32789
    United States

    Active - Recruiting

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

    Gulf Breeze 4157634, Florida 4155751 32561
    United States

    Site Not Available

  • Auzmer Research /ID# 271158

    Lakeland 4161438, Florida 4155751 33813
    United States

    Site Not Available

  • My Preferred Research /ID# 270312

    Miami 4164138, Florida 4155751 33155
    United States

    Site Not Available

  • Encore Medical Research - Weston /ID# 271139

    Weston 4178003, Florida 4155751 33331
    United States

    Site Not Available

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

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Deaconess Midtown Hospital /ID# 270572

    Evansville, Indiana 47710
    United States

    Active - Recruiting

  • Deaconess Midtown Hospital /ID# 270572

    Evansville 4257227, Indiana 4921868 47710
    United States

    Site Not Available

  • Michigan Headache & Neurological Institute /ID# 270942

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Michigan Headache & Neurological Institute /ID# 270942

    Ann Arbor 4984247, Michigan 5001836 48104
    United States

    Site Not Available

  • Proven Endpoints LLC /ID# 270269

    Ridgeland, Mississippi 39157
    United States

    Active - Recruiting

  • Proven Endpoints LLC /ID# 270269

    Ridgeland 4443296, Mississippi 4436296 39157
    United States

    Site Not Available

  • Cct Research - Papillion Research Center /ID# 270393

    Papillion, Nebraska 68046
    United States

    Active - Recruiting

  • Cct Research - Papillion Research Center /ID# 270393

    Papillion 5074792, Nebraska 5073708 68046
    United States

    Site Not Available

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

    Nashua, New Hampshire 03060
    United States

    Active - Recruiting

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

    Nashua 5090046, New Hampshire 5090174 03060
    United States

    Site Not Available

  • Dent Neurologic Institute - Amherst /ID# 270260

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Dent Neurologic Institute - Amherst /ID# 270260

    Amherst 5107129, New York 5128638 14226
    United States

    Site Not Available

  • Headache Wellness Center /ID# 270568

    Greensboro, North Carolina 27405
    United States

    Active - Recruiting

  • Headache Wellness Center /ID# 270568

    Greensboro 4469146, North Carolina 4482348 27405
    United States

    Site Not Available

  • Frontier Clinical Research - Scottdale /ID# 270854

    Scottdale, Pennsylvania 15683
    United States

    Active - Recruiting

  • Frontier Clinical Research - Smithfield /ID# 270849

    Smithfield, Pennsylvania 15478
    United States

    Active - Recruiting

  • Frontier Clinical Research - Scottdale /ID# 270854

    Scottdale 5211279, Pennsylvania 6254927 15683
    United States

    Site Not Available

  • Frontier Clinical Research - Smithfield /ID# 270849

    Smithfield 4561301, Pennsylvania 6254927 15478
    United States

    Site Not Available

  • Access Clinical Trials Inc /ID# 270280

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Access Clinical Trials Inc /ID# 270280

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

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

    Austin, Texas 78723-3079
    United States

    Active - Recruiting

  • Earle Research /ID# 270424

    Houston, Texas 77058
    United States

    Active - Recruiting

  • Clinpoint Trials /ID# 270261

    Waxahachie, Texas 75165
    United States

    Active - Recruiting

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

    Austin 4671654, Texas 4736286 78723-3079
    United States

    Site Not Available

  • Earle Research /ID# 270424

    Houston 4699066, Texas 4736286 77058
    United States

    Site Not Available

  • Clinpoint Trials /ID# 270261

    Waxahachie 4740328, Texas 4736286 75165
    United States

    Site Not Available

  • Pantheon Clinical Research /ID# 270259

    Bountiful, Utah 84010
    United States

    Active - Recruiting

  • Alpine Research Organization - Clinton /ID# 276527

    Clinton, Utah 84015
    United States

    Active - Recruiting

  • Highland Clinical Research /ID# 270281

    Salt Lake City, Utah 84124
    United States

    Active - Recruiting

  • Pantheon Clinical Research /ID# 270259

    Bountiful 5771826, Utah 5549030 84010
    United States

    Site Not Available

  • Alpine Research Organization - Clinton /ID# 276527

    Clinton 5773001, Utah 5549030 84015
    United States

    Site Not Available

  • Highland Clinical Research /ID# 270281

    Salt Lake City 5780993, Utah 5549030 84124
    United States

    Site Not Available

  • Frontier Clinical Research - Kingwood /ID# 271053

    Kingwood, West Virginia 26537
    United States

    Active - Recruiting

  • Frontier Clinical Research - Kingwood /ID# 271053

    Kingwood 4811007, West Virginia 4826850 26537
    United States

    Site Not Available

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