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 | Recruiting Phase 3

• 3 other identifiers: M23-7122024-513836-282024-513836-28-00
• Study Type: interventional
• Target: 420
• Locations: 11 countries
• Sites: 61

Brief 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.

Conditions

Chronic Migraine

Keywords

Migraine; Chronic Migraine; Atogepant; QULIPTA; AQUIPTA

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to approximately 16 weeks

• 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.

  Baseline (Week 0) through Week 12

Secondary Outcomes (5)

• Change From Baseline in Mean Monthly Headache Days

  Baseline (Week 0) through Week 12

• Change From Baseline in Mean Monthly Acute Medication Use Days

  Baseline (Week 0) through Week 12

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

  Baseline (Week 0) through Week 12

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

  Baseline (Week 0) through Week 12

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

  Baseline (Week 0) through Week 12

Study Arms (2)

Atogepant

EXPERIMENTAL

Participants will receive atogepant once daily for 12 weeks.

Drug: Atogepant

Placebo for Atogepant

PLACEBO COMPARATOR

Participants will receive placebo for atogepant once daily for 12 weeks.

Drug: Placebo for Atogepant

Interventions

Atogepant DRUG

Oral tablet

Also known as: Qulipta, Aquipta

Atogepant

Placebo for Atogepant DRUG

Oral tablet

Placebo for Atogepant

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

Rehabilitation & Neurological Services /ID# 270782

Huntsville, Alabama, 35805, United States

RECRUITING

Preferred Research Partner, Inc /ID# 270389

Little Rock, Arkansas, 72211, United States

RECRUITING

Preferred Research Partners /ID# 270419

Little Rock, Arkansas, 72211, United States

COMPLETED

Advanced Research Center /ID# 270257

Anaheim, California, 92805, United States

RECRUITING

Neuro Pain Research Center /ID# 271048

Fresno, California, 93710, United States

RECRUITING

Accellacare - Long Beach /ID# 270398

Long Beach, California, 90807, United States

RECRUITING

Excell Research /ID# 270258

Oceanside, California, 92056, United States

RECRUITING

Lumos Clinical Research Center /ID# 270582

San Jose, California, 95124, United States

RECRUITING

Sunwise Clinical Research /ID# 270431

Walnut Creek, California, 94596, United States

RECRUITING

Northwest Florida Clinical Research Group, LLC /ID# 270833

Gulf Breeze, Florida, 32561, United States

RECRUITING

Auzmer Research /ID# 271158

Lakeland, Florida, 33813, United States

COMPLETED

My Preferred Research /ID# 270312

Miami, Florida, 33155, United States

RECRUITING

Encore Medical Research - Weston /ID# 271139

Weston, Florida, 33331, United States

RECRUITING

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

Winter Park, Florida, 32789, United States

RECRUITING

Deaconess Midtown Hospital /ID# 270572

Evansville, Indiana, 47710, United States

RECRUITING

Michigan Headache & Neurological Institute /ID# 270942

Ann Arbor, Michigan, 48104, United States

RECRUITING

Proven Endpoints LLC /ID# 270269

Ridgeland, Mississippi, 39157, United States

RECRUITING

Cct Research - Papillion Research Center /ID# 270393

Papillion, Nebraska, 68046, United States

RECRUITING

Healthy Perspectives - Innovate Mental Health Services /ID# 270847

Nashua, New Hampshire, 03060, United States

RECRUITING

Dent Neurologic Institute - Amherst /ID# 270260

Amherst, New York, 14226, United States

RECRUITING

Headache Wellness Center /ID# 270568

Greensboro, North Carolina, 27405, United States

RECRUITING

Frontier Clinical Research - Scottdale /ID# 270854

Scottdale, Pennsylvania, 15683, United States

RECRUITING

Frontier Clinical Research - Smithfield /ID# 270849

Smithfield, Pennsylvania, 15478, United States

RECRUITING

Access Clinical Trials Inc /ID# 270280

Nashville, Tennessee, 37203, United States

RECRUITING

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

Austin, Texas, 78723-3079, United States

RECRUITING

Earle Research /ID# 270424

Houston, Texas, 77058, United States

RECRUITING

Clinpoint Trials /ID# 270261

Waxahachie, Texas, 75165, United States

RECRUITING

Pantheon Clinical Research /ID# 270259

Bountiful, Utah, 84010, United States

RECRUITING

Alpine Research Organization - Clinton /ID# 276527

Clinton, Utah, 84015, United States

RECRUITING

Highland Clinical Research /ID# 270281

Salt Lake City, Utah, 84124, United States

RECRUITING

Frontier Clinical Research - Kingwood /ID# 271053

Kingwood, West Virginia, 26537, United States

RECRUITING

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

London, Ontario, N6A 5W9, Canada

RECRUITING

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

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Herlev Hospital /ID# 270482

Herlev, Capital Region, 2730, Denmark

RECRUITING

Regionshospitalet Godstrup /ID# 270481

Herning, Central Jutland, 7400, Denmark

RECRUITING

Semmelweis Egyetem /ID# 271219

Budapest, 1085, Hungary

RECRUITING

Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500

Budapest, 1141, Hungary

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756

Milan, Milano, 20133, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù /ID# 270759

Rome, Roma, 00165, Italy

RECRUITING

Konan Medical Center /ID# 270486

Kobe, Hyōgo, 658-0064, Japan

RECRUITING

Umenotsuji Clinic /ID# 270484

Kochi, Kochi, 780-8011, Japan

RECRUITING

Tominaga Clinic - Osaka /ID# 270483

Osaka, Osaka, 556-0015, Japan

RECRUITING

Tokyo Headache Clinic /ID# 271610

Shibuya-ku, Tokyo, 151-0051, Japan

RECRUITING

Tokyo Medical University Hospital /ID# 270487

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Tendo Brain Clinic /ID# 271410

Tendo-shi, Yamagata, 994-0083, Japan

RECRUITING

Nagaseki Headache Clinic /ID# 271699

Kai, Yamanashi, 400-0124, Japan

RECRUITING

Tanaka Neurosurgery & Headache Clinic /ID# 271346

Kagoshima, 890-0052, Japan

RECRUITING

Canisius-Wilhelmina Ziekenhuis /ID# 270374

Nijmegen, Gelderland, 6532 SZ, Netherlands

RECRUITING

HagaZiekenhuis /ID# 270379

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

Clinical Research Center Medic-R /ID# 270235

Poznan, Greater Poland Voivodeship, 60-848, Poland

RECRUITING

Athleticomed Sp. z o.o /ID# 270243

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

RECRUITING

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

Krakow, Lesser Poland Voivodeship, 30-539, Poland

RECRUITING

MIGRE Polskie Centrum Leczenia Migreny /ID# 270239

Wroclaw, Lower Silesian Voivodeship, 52-210, Poland

RECRUITING

Oha-Med Sp. Z O.O /ID# 270242

Warsaw, Masovian Voivodeship, 01-018, Poland

RECRUITING

Hospital da Luz /ID# 277991

Lisbon, Lisbon District, 1500-650, Portugal

RECRUITING

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

Almada, Setúbal District, 2805-267, Portugal

RECRUITING

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

Porto, 4099-003, Portugal

RECRUITING

CMRC Headlands LLC /ID# 271300

San Juan, 00918-3501, Puerto Rico

RECRUITING

Medway Maritime Hospital /ID# 271885

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

Royal Aberdeen Children's Hospital /ID# 271664

Aberdeen, Scotland, AB25 2ZG, United Kingdom

RECRUITING

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

Stockport, SK2 7JE, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 5, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DK (2); HU (2); PR (1); PT (3); NL (2); PL (5); GB (3); JP (8); CA (2); US (31); IT (2)