A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine

NCT05711394 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M21-2012022-501100-94-00
• Study Type: interventional
• Target: 450
• Locations: 16 countries
• Sites: 98

Brief Summary

A migraine is a 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Conditions

Episodic Migraine

Keywords

Episodic Migraine; Atogepant; QULIPTA; AGN-241689

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Mean 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.

  Baseline (Week 0) through Week 12

• Number of Participants Experiencing Adverse Events

  An 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.

  Baseline (Week 0) through Week 16

Secondary Outcomes (6)

• Change from Baseline in Mean Monthly Headache Days

  Baseline (Week 0) through Week 12

• Change from Baseline in Mean Monthly Headache Days of at Least Moderate Severity

  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 Average of Monthly Migraine Days

  Baseline (Week 0) to 3 Months

• Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score

  Baseline (Week 0) through Week 12

Study Arms (8)

Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)

EXPERIMENTAL

Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Drug: Atogepant

Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)

EXPERIMENTAL

Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.

Drug: Atogepant

Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)

EXPERIMENTAL

Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Drug: Atogepant

Double-Blind Treatment Period: Placebo (12-17 yrs)

PLACEBO COMPARATOR

Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Drug: Placebo-Matching Atogepant

Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)

EXPERIMENTAL

Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Drug: Atogepant

Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)

EXPERIMENTAL

Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.

Drug: Atogepant

Double-Blind Treatment Period: Placebo (6-11 yrs)

PLACEBO COMPARATOR

Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.

Drug: Placebo-Matching Atogepant

Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)

EXPERIMENTAL

Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.

Drug: Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: QULIPTA, AGN-241689

Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs); Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs); Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs); Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs); Open-Label PK Substudy: Atogepant Dose A (6-11 yrs); Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)

Placebo-Matching Atogepant DRUG

Oral Tablet

Double-Blind Treatment Period: Placebo (12-17 yrs); Double-Blind Treatment Period: Placebo (6-11 yrs)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
• History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
• Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
• To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.

You may not qualify if:

• History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
• Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
• Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (98)

Rehabilitation & Neurological Services /ID# 248517

Huntsville, Alabama, 35805-4046, United States

RECRUITING

The Center for Clinical Trials - Saraland /ID# 271604

Saraland, Alabama, 36571, United States

RECRUITING

Preferred Research Partners /ID# 249729

Little Rock, Arkansas, 72211, United States

RECRUITING

Preferred Research Partners /ID# 270406

Little Rock, Arkansas, 72211, United States

COMPLETED

Advanced Research Center /ID# 251381

Anaheim, California, 92805, United States

RECRUITING

Alliance for Research Alliance for Wellness /ID# 248521

Long Beach, California, 90807, United States

RECRUITING

Excell Research, Inc /ID# 247532

Oceanside, California, 92056, United States

RECRUITING

Lumos Clinical Research Center /ID# 249731

San Jose, California, 95124-4108, United States

RECRUITING

Sunwise Clinical Research /ID# 248529

Walnut Creek, California, 94596, United States

RECRUITING

Advanced Neurosciences Research, LLC /ID# 247592

Fort Collins, Colorado, 80528, United States

COMPLETED

Northwest Florida Clinical Research Group, LLC /ID# 251382

Gulf Breeze, Florida, 32561-4495, United States

RECRUITING

Advanced Research Institute of Miami /ID# 248539

Homestead, Florida, 33030-4613, United States

RECRUITING

My Preferred Research LLC /ID# 249720

Miami, Florida, 33155, United States

RECRUITING

Asclepes Research Centers - Spring Hill /ID# 248525

Spring Hill, Florida, 34609-5692, United States

COMPLETED

Coastal Georgia Child Neurology /ID# 249733

Brunswick, Georgia, 31520-1601, United States

RECRUITING

Deaconess Clinic - Gateway Health Center /ID# 247589

Newburgh, Indiana, 47630, United States

RECRUITING

College Park Family Care Center Overland Park /ID# 249734

Overland Park, Kansas, 66210-2761, United States

COMPLETED

Michigan Headache & Neurological Institute (MHNI) /ID# 247468

Ann Arbor, Michigan, 48104-5131, United States

RECRUITING

Proven Endpoints LLC /ID# 258066

Ridgeland, Mississippi, 39157, United States

RECRUITING

Cognitive Clinical Trials (CCT) - Papillion /ID# 248536

Papillion, Nebraska, 68046-4131, United States

RECRUITING

Goryeb Childrens Hospital /ID# 249724

Morristown, New Jersey, 07960, United States

RECRUITING

Dent Neurologic Institute - Amherst /ID# 248534

Amherst, New York, 14226, United States

RECRUITING

Modern Migraine MD /ID# 258074

New York, New York, 10001, United States

COMPLETED

Headache Wellness Center /ID# 251018

Greensboro, North Carolina, 27405, United States

RECRUITING

Patient Priority Clinical Sites, LLC /ID# 247535

Cincinnati, Ohio, 45215-2123, United States

RECRUITING

Cincinnati Childrens Hospital Medical Center /ID# 258070

Cincinnati, Ohio, 45229, United States

RECRUITING

CincyScience /ID# 249726

West Chester, Ohio, 45069, United States

COMPLETED

Lynn Institute of Oklahoma City /ID# 247600

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Children's Hospital of Philadelphia - Main /ID# 258071

Philadelphia, Pennsylvania, 19104-4319, United States

RECRUITING

Le Bonheur Children's Hospital /ID# 261084

Memphis, Tennessee, 38103, United States

RECRUITING

Access Clinical Trials, Inc. /ID# 248532

Nashville, Tennessee, 37203, United States

RECRUITING

UT Health Austin at Dell Children's Neurology Clinic /ID# 264082

Austin, Texas, 78723-3079, United States

RECRUITING

FutureSearch Trials of Neurology /ID# 247470

Austin, Texas, 78731, United States

RECRUITING

3A Research - East El Paso /ID# 248516

El Paso, Texas, 79925-7945, United States

RECRUITING

Earle Research /ID# 248501

Friendswood, Texas, 77546, United States

RECRUITING

Family Psychiatry of The Woodlands /ID# 249727

The Woodlands, Texas, 77381, United States

RECRUITING

ClinPoint Trials /ID# 248540

Waxahachie, Texas, 75165-1430, United States

RECRUITING

Pantheon Clinical Research /ID# 251601

Bountiful, Utah, 84010-4968, United States

RECRUITING

Alpine Research Organization - Clinton /ID# 276497

Clinton, Utah, 84015, United States

RECRUITING

Highland Clinical Research /ID# 247590

Salt Lake City, Utah, 84124, United States

RECRUITING

Office of Maria Ona /ID# 249738

Franklin, Virginia, 23851, United States

RECRUITING

Core Clinical Research /ID# 249721

Everett, Washington, 98201, United States

COMPLETED

Uza /Id# 247339

Edegem, Antwerpen, 2650, Belgium

RECRUITING

AZ Sint-Jan Brugge /ID# 247201

Bruges, West-Vlaanderen, 8000, Belgium

RECRUITING

Stollery Children's Hospital /ID# 249672

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

London Health Sciences Center- University Hospital /ID# 252979

London, Ontario, N6A 5W9, Canada

RECRUITING

McGill University Health Centre - Glen Site. /ID# 247271

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Herlev Hospital /ID# 247724

Herlev, Capital Region, 2730, Denmark

RECRUITING

Regionshospitalet Godstrup /ID# 247902

Herning, Central Jutland, 7400, Denmark

RECRUITING

Aalborg Sygehus Nord /ID# 247428

Aalborg, North Denmark, 9000, Denmark

RECRUITING

CHU Amiens-Picardie Site Sud /ID# 248833

Amiens, Somme, 80054, France

COMPLETED

Centre Hosp Intercommunal de Creteil /ID# 248832

Créteil, Val-de-Marne, 94000, France

RECRUITING

CHU Toulouse - Hôpital des enfants /ID# 247553

Toulouse, 31059, France

RECRUITING

MIND Clinic /ID# 248687

Budapest, 1024, Hungary

COMPLETED

Semmelweis Egyetem /ID# 248360

Budapest, 1085, Hungary

RECRUITING

Shamir Medical Center /ID# 256857

Beer Ya'akov, Central District, 70300, Israel

RECRUITING

Hillel Yaffe Medical Center /ID# 246747

Hadera, Haifa District, 38100, Israel

COMPLETED

The Chaim Sheba Medical Center /ID# 246746

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 247466

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

Bnai Zion Medical Center /ID# 247469

Haifa, 3339419, Israel

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581

Milan, Milano, 20133, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù /ID# 247647

Rome, Roma, 00165, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638

Palermo, 90127, Italy

RECRUITING

Konan Medical Center /ID# 254457

Kobe, Hyōgo, 658-0064, Japan

RECRUITING

Yamaguchi Clinic /ID# 254753

Nishinomiya, Hyōgo, 663-8204, Japan

RECRUITING

Umenotsuji Clinic /ID# 254453

Kochi, Kochi, 780-8011, Japan

RECRUITING

Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211

Sendai, Miyagi, 982-0014, Japan

RECRUITING

Tominaga Clinic - Osaka /ID# 254450

Osaka, Osaka, 556-0015, Japan

RECRUITING

Tokyo Medical University Hospital /ID# 254459

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Tatsuoka Neurology Clinic /ID# 254455

Kyoto, 600-8811, Japan

RECRUITING

Canisius-Wilhelmina Ziekenhuis /ID# 253065

Nijmegen, Gelderland, 6532 SZ, Netherlands

RECRUITING

HagaZiekenhuis /ID# 247318

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301

Terneuzen, Zeeland, 4535 PA, Netherlands

RECRUITING

Clinical Research Center Medic-R /ID# 247383

Poznan, Greater Poland Voivodeship, 60-848, Poland

RECRUITING

Athleticomed Sp. z o.o /ID# 248789

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

RECRUITING

Specjalistyczne Gabinety Sp. z o.o. /ID# 247384

Krakow, Lesser Poland Voivodeship, 30-539, Poland

RECRUITING

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382

Lublin, Lublin Voivodeship, 20-582, Poland

RECRUITING

Oha-Med Sp. Z O.O /ID# 248614

Warsaw, Masovian Voivodeship, 01-018, Poland

RECRUITING

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381

Wroclaw, 52-210, Poland

RECRUITING

Clinical Research Investigator Group, LLC /ID# 261254

Bayamón, 00960, Puerto Rico

COMPLETED

Dr. Samuel Sanchez PSC /ID# 248495

Caguas, 00727, Puerto Rico

RECRUITING

Puerto Rico Health Institute /ID# 249741

Dorado, 00646, Puerto Rico

RECRUITING

CMRC Headlands LLC /ID# 251634

San Juan, 00918-3501, Puerto Rico

RECRUITING

PRCCI Clinical Research Center /ID# 262726

San Juan, 00927, Puerto Rico

COMPLETED

Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431

Bucharest, București, 022102, Romania

COMPLETED

Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595

Cluj-Napoca, Cluj, 400012, Romania

COMPLETED

Delta Health Care S.R.L /ID# 248130

Bucharest, 014146, Romania

COMPLETED

Hospital Universitario Vall de Hebron /ID# 247967

Barcelona, 08035, Spain

RECRUITING

Hospital Clinico San Carlos /ID# 249267

Madrid, 28040, Spain

RECRUITING

Hospital Universitario 12 de Octubre /ID# 275578

Madrid, 28041, Spain

RECRUITING

Hospital Universitario Virgen del Rocio /ID# 248632

Seville, 41013, Spain

RECRUITING

Hospital Universitario y Politecnico La Fe /ID# 247969

Valencia, 46026, Spain

COMPLETED

Sodersjukhuset /ID# 248279

Stockholm, Stockholm County, 118 83, Sweden

RECRUITING

Vastra Gotealandsregionen Regionhalsan /ID# 248277

Mölnlycke, 435 30, Sweden

RECRUITING

Great Ormond Street Children's Hospital /ID# 262933

London, Greater London, WC1N 3HZ, United Kingdom

RECRUITING

Medway NHS Foundation Trust /ID# 249065

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

NHS Grampian /ID# 249067

Aberdeen, AB15 6RE, United Kingdom

RECRUITING

Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121

Stockport, SK2 7JE, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

atogepant

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 3, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

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

NL (3); PL (6); FR (3); RO (3); PR (5); CA (3); DK (3); JP (7); ES (5); BE (2); GB (4); US (42); SE (2); IL (5); IT (3); HU (2)