Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

NCT05707949 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 2 other identifiers: M21-1992022-501099-24-00
• Study Type: interventional
• Target: 650
• Locations: 16 countries
• Sites: 86

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 participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. 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 migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 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

Migraine Prophylaxis

Keywords

Migraine Prophylaxis; Atogepant; QULIPTA; AGN-241689

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants with Adverse Events (AEs)

  AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.

  Up to 56 Weeks

• Percentage of Participants with Potentially Clinically Significant Lab Values

  Percentage of participants with abnormal change in clinical laboratory test results like hematology, chemistry and urinalysis will be assessed.

  Up to 52 Weeks

• Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)

  12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).

  Up to 52 Weeks

• Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters

  Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.

  Up to 52 Weeks

• Percentage of with Participants with Treatment-Emergent Suicidal Ideations with Intent, with or without a Plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]), or any Suicidal Behaviors

  The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods \[not plan\] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt).

  Up to 52 Weeks

• Percentage of Participants with Change in Menstrual Cycle (Female Participants Only)

  Female participants who have entered menarche are to be asked for the date of the first and last day of their most recent menstrual period.

  Up to 52 Weeks

• Change from Baseline in Tanner Staging Score

  Tanner's staging is used to assess growth and pubertal development.

  Baseline (Week 0) through Week 52

• Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire

  The BRIEF 2 is an 86-item questionnaire assessing executive function. It consists of 2 indexes, Behavioral Regulation and Metacognition, which are then used to calculate an overall composite score. Higher scores indicate more executive difficulties

  Baseline (Week 0) through Week 52

Study Arms (2)

Atogepant Dose A (12-17 yrs)

EXPERIMENTAL

Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.

Drug: Atogepant

Atogepant Dose B (6-11 yrs)

EXPERIMENTAL

Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.

Drug: Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: QULIPTA, AGN-241689

Atogepant Dose A (12-17 yrs); Atogepant Dose B (6-11 yrs)

Eligibility Criteria

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

You may qualify if:

• Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
• The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
• Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
• A history of 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.

You may not qualify if:

• 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).
• Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (86)

Rehabilitation & Neurological Services /ID# 250910

Huntsville, Alabama, 35805-4046, United States

Location

Preferred Research Partners /ID# 250937

Little Rock, Arkansas, 72211, United States

Location

Advanced Research Center /ID# 251616

Anaheim, California, 92805, United States

Location

Sunwise Clinical Research /ID# 250913

Lafayette, California, 94549-4579, United States

Location

Alliance for Research Alliance for Wellness /ID# 250911

Long Beach, California, 90807, United States

Location

Excell Research, Inc /ID# 251611

Oceanside, California, 92056, United States

Location

Lumos Clinical Research Center /ID# 251608

San Jose, California, 95124-4108, United States

Location

Advanced Neurosciences Research, LLC /ID# 250925

Fort Collins, Colorado, 80528, United States

Location

Northwest Florida Clinical Research Group, LLC /ID# 251614

Gulf Breeze, Florida, 32561-4495, United States

Location

Advanced Research Institute of Miami /ID# 250916

Homestead, Florida, 33030-4613, United States

Location

My Preferred Research LLC /ID# 250931

Miami, Florida, 33155, United States

Location

Asclepes Research Centers - Spring Hill /ID# 250912

Spring Hill, Florida, 34609-5692, United States

Location

Coastal Georgia Child Neurology /ID# 250938

Brunswick, Georgia, 31520-1601, United States

Location

Deaconess Clinic - Gateway Health Center /ID# 250923

Newburgh, Indiana, 47630, United States

Location

College Park Family Care Center Overland Park /ID# 251609

Overland Park, Kansas, 66210-2761, United States

Location

Michigan Headache & Neurological Institute (MHNI) /ID# 250920

Ann Arbor, Michigan, 48104-5131, United States

Location

Proven Endpoints LLC /ID# 258083

Ridgeland, Mississippi, 39157, United States

Location

Cognitive Clinical Trials (CCT) - Papillion /ID# 251610

Papillion, Nebraska, 68046-4131, United States

Location

Goryeb Children's Hospital /ID# 250934

Morristown, New Jersey, 07960, United States

Location

Dent Neurosciences Research Center, Inc. /ID# 250915

Amherst, New York, 14226, United States

Location

Modern Migraine MD /ID# 258082

New York, New York, 10001, United States

Location

Headache Wellness Center /ID# 251612

Greensboro, North Carolina, 27405, United States

Location

Patient Priority Clinical Sites, LLC /ID# 250922

Cincinnati, Ohio, 45215-2123, United States

Location

CincyScience /ID# 250935

West Chester, Ohio, 45069, United States

Location

Lynn Institute of Oklahoma City /ID# 250926

Oklahoma City, Oklahoma, 73112, United States

Location

Access Clinical Trials, Inc. /ID# 250914

Nashville, Tennessee, 37203, United States

Location

FutureSearch Trials of Neurology /ID# 251613

Austin, Texas, 78731, United States

Location

3A Research - East El Paso /ID# 250909

El Paso, Texas, 79925-7945, United States

Location

Earle Research /ID# 250908

Friendswood, Texas, 77546, United States

Location

Family Psychiatry of The Woodlands /ID# 250936

The Woodlands, Texas, 77381, United States

Location

ClinPoint Trials /ID# 250942

Waxahachie, Texas, 75165-1430, United States

Location

Pantheon Clinical Research /ID# 251615

Bountiful, Utah, 84010-4968, United States

Location

Highland Clinical Research /ID# 250924

Salt Lake City, Utah, 84124, United States

Location

Office of Maria Ona /ID# 250939

Franklin, Virginia, 23851, United States

Location

Core Clinical Research /ID# 250932

Everett, Washington, 98201, United States

Location

Uza /Id# 247885

Edegem, Antwerpen, 2650, Belgium

Location

AZ Sint-Jan Brugge /ID# 247527

Bruges, 8000, Belgium

Location

Stollery Children's Hospital /ID# 251426

Edmonton, Alberta, T6G 2B7, Canada

Location

Montreal Children's Hospital /ID# 250649

Montreal, Quebec, H4A 3J1, Canada

Location

Herlev Hospital /ID# 247725

Herlev, Capital Region, 2730, Denmark

Location

Regionshospitalet Godstrup /ID# 247903

Herning, Central Jutland, 7400, Denmark

Location

Aalborg Universitetshospital /Id# 247429

Aalborg, North Denmark, 9000, Denmark

Location

CHU Amiens-Picardie Site Sud /ID# 251377

Amiens, Somme, 80054, France

Location

Centre Hosp Intercommunal de Creteil /ID# 251199

Créteil, Val-de-Marne, 94000, France

Location

CHU Toulouse - Hôpital des enfants /ID# 251201

Toulouse, 31059, France

Location

Semmelweis Egyetem /ID# 251593

Budapest, Budapest, 1085, Hungary

Location

Mind Klinika Kft. /ID# 251597

Budapest, 1024, Hungary

Location

Shamir Medical Center /ID# 256858

Beer Ya'akov, Central District, 70300, Israel

Location

Hillel Yaffe Medical Center /ID# 248923

Hadera, H_efa, 38100, Israel

Location

Bnai Zion Medical Center /ID# 251132

Haifa, H_efa, 3339419, Israel

Location

The Chaim Sheba Medical Center /ID# 248990

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 251133

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182

Milan, Milano, 20133, Italy

Location

Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184

Palermo, Palermo, 90127, Italy

Location

Konan Medical Center /ID# 254458

Kobe, Hyōgo, 658-0064, Japan

Location

Yamaguchi Clinic /ID# 254763

Nishinomiya-shi, Hyōgo, 663-8204, Japan

Location

Umenotsuji Clinic /ID# 254454

Kochi, Kochi, 780-8011, Japan

Location

Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212

Sendai, Miyagi, 982-0014, Japan

Location

Tominaga Clinic /ID# 254451

Osaka, Osaka, 5560015, Japan

Location

Tokyo Medical University Hospital /ID# 254460

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Tatsuoka Neurology Clinic /ID# 254456

Kyoto, 600-8811, Japan

Location

Canisius-Wilhelmina Ziekenhuis /ID# 253067

Nijmegen, 6532 SZ, Netherlands

Location

ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603

Terneuzen, 4535 PA, Netherlands

Location

HagaZiekenhuis /ID# 251655

The Hague, 2545 AA, Netherlands

Location

Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623

Poznan, Greater Poland Voivodeship, 61-731, Poland

Location

Athleticomed Sp. z o.o /ID# 250620

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

Location

Specjalistyczne Gabinety Sp. z o.o. /ID# 250625

Krakow, Lesser Poland Voivodeship, 30-539, Poland

Location

Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622

Lublin, Lublin Voivodeship, 20-582, Poland

Location

OHA-MED sp. z o.o /ID# 250621

Warsaw, Masovian Voivodeship, 00-414, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624

Wroclaw, 52-210, Poland

Location

Clinical Research Investigator Group, LLC /ID# 261251

Bayamón, Puerto Rico, 00960, Puerto Rico

Location

Dr. Samuel Sanchez PSC /ID# 261670

Caguas, Puerto Rico, 00727, Puerto Rico

Location

Puerto Rico Health Institute /ID# 250949

Dorado, Puerto Rico, 00646, Puerto Rico

Location

Caribbean Medical Research Center /ID# 253156

San Juan, Puerto Rico, 00918-3501, Puerto Rico

Location

PRCCI Clinical Research Center /ID# 264232

San Juan, Puerto Rico, 00927, Puerto Rico

Location

Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997

Bucharest, București, 022102, Romania

Location

Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112

Cluj-Napoca, Cluj, 400012, Romania

Location

Delta Health Care S.R.L /ID# 250996

Bucharest, 014146, Romania

Location

Hospital Universitario Vall d'Hebron /ID# 248457

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clinico San Carlos /ID# 249268

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 248633

Seville, Sevilla, 41013, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 248459

Valencia, Valencia, 46026, Spain

Location

Vastra Gotealandsregionen Regionhalsan /ID# 248981

Mölnlycke, 435 30, Sweden

Location

Sodersjukhuset /ID# 250671

Stockholm, 118 83, Sweden

Location

NHS Grampian /ID# 251474

Aberdeen, AB15 6RE, United Kingdom

Location

Stockport NHS foundation trust /ID# 261562

Stockport, SK2 7JE, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Interventions

atogepant

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 1, 2023
• Study Start: June 5, 2023
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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

US (35); NL (3); PL (6); IT (2); ES (4); BE (2); DK (3); HU (2); SE (2); GB (2); PR (5); JP (7); CA (2); IL (5); RO (3); FR (3)