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

August 6, 2025 updated by: AbbVie

A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

650

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 Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan Brugge /ID# 247527
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Uza /Id# 247885
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital /ID# 251426
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Montreal Children's Hospital /ID# 250649
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 247725
    • Midtjylland
      • Herning, Midtjylland, Denmark, 7400
        • Regionshospitalet Godstrup /ID# 247903
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg Universitetshospital /Id# 247429
  • France
      • Toulouse CEDEX 9, France, 31059
        • CHU Toulouse - Hôpital des enfants /ID# 251201
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 251377
    • Val-de-Marne
      • Creteil, Val-de-Marne, France, 94000
        • Centre Hosp Intercommunal de Creteil /ID# 251199
  • Hungary
      • Budapest, Hungary, 1024
        • Mind Klinika Kft. /ID# 251597
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 251593
  • Israel
    • H_efa
      • Hadera, H_efa, Israel, 38100
        • Hillel Yaffe Medical Center /ID# 248923
      • Haifa, H_efa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 251132
    • HaMerkaz
      • Beer Ya'akov, HaMerkaz, Israel, 70300
        • Shamir Medical Center /ID# 256858
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • The Chaim Sheba Medical Center /ID# 248990
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center /ID# 251133
  • Italy
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182
      • Palermo, Italy, 90127
        • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184
  • Japan
      • Kyoto, Japan, 600-8811
        • Tatsuoka Neurology Clinic /ID# 254456
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 658-0064
        • Konan Medical Center /ID# 254458
      • Nishinomiya-shi, Hyogo, Japan, 663-8204
        • Yamaguchi Clinic /ID# 254763
    • Kochi
      • Kochi-shi, Kochi, Japan, 780-8011
        • Umenotsuji Clinic /ID# 254454
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 982-0014
        • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212
    • Osaka
      • Osaka-shi, Osaka, Japan, 5560015
        • Tominaga Clinic /ID# 254451
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 254460
  • Netherlands
      • Den Haag, Netherlands, 2545 AA
        • HagaZiekenhuis /ID# 251655
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis /ID# 253067
      • Terneuzen, Netherlands, 4535 PA
        • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603
  • Poland
      • Wroclaw, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-752
        • Athleticomed Sp. z o.o /ID# 250620
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-539
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 250625
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-414
        • OHA-MED sp. z o.o /ID# 250621
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-731
        • Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623
  • Puerto Rico
      • Bayamon, Puerto Rico, 00960
        • Clinical Research Investigator Group, LLC /ID# 261251
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC /ID# 261670
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health Institute /ID# 250949
      • San Juan, Puerto Rico, 00918-3501
        • Caribbean Medical Research Center /ID# 253156
      • San Juan, Puerto Rico, 00927
        • PRCCI Clinical Research Center /ID# 264232
  • Romania
      • Bucharest, Romania, 014146
        • Delta Health Care S.R.L /ID# 250996
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 022102
        • Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400012
        • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron /ID# 248457
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos /ID# 249268
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio /ID# 248633
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 248459
  • Sweden
      • Molnlycke, Sweden, 435 30
        • Vastra Gotealandsregionen Regionhalsan /ID# 248981
      • Stockholm, Sweden, 118 83
        • Sodersjukhuset /ID# 250671
  • United Kingdom
      • Aberdeen, United Kingdom, AB15 6RE
        • NHS Grampian /ID# 251474
      • Stockport, United Kingdom, SK2 7JE
        • Stockport NHS foundation trust /ID# 261562
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-4046
        • Rehabilitation & Neurological Services /ID# 250910
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners /ID# 250937
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center /ID# 251616
      • Lafayette, California, United States, 94549-4579
        • Sunwise Clinical Research /ID# 250913
      • Long Beach, California, United States, 90807
        • Alliance for Research Alliance for Wellness /ID# 250911
      • Oceanside, California, United States, 92056
        • Excell Research, Inc /ID# 251611
      • San Jose, California, United States, 95124-4108
        • Lumos Clinical Research Center /ID# 251608
    • Colorado
      • Ft. Collins, Colorado, United States, 80528
        • Advanced Neurosciences Research, LLC /ID# 250925
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4495
        • Northwest Florida Clinical Research Group, LLC /ID# 251614
      • Homestead, Florida, United States, 33030-4613
        • Advanced Research Institute of Miami /ID# 250916
      • Miami, Florida, United States, 33155
        • My Preferred Research LLC /ID# 250931
      • Spring Hill, Florida, United States, 34609-5692
        • Asclepes Research Centers - Spring Hill /ID# 250912
    • Georgia
      • Brunswick, Georgia, United States, 31520-1601
        • Coastal Georgia Child Neurology /ID# 250938
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic - Gateway Health Center /ID# 250923
    • Kansas
      • Overland Park, Kansas, United States, 66210-2761
        • College Park Family Care Center Overland Park /ID# 251609
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Michigan Headache & Neurological Institute (MHNI) /ID# 250920
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Proven Endpoints LLC /ID# 258083
    • Nebraska
      • Papillion, Nebraska, United States, 68046-4131
        • Cognitive Clinical Trials (CCT) - Papillion /ID# 251610
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Goryeb Children's Hospital /ID# 250934
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center, Inc. /ID# 250915
      • New York, New York, United States, 10001
        • Modern Migraine MD /ID# 258082
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellness Center /ID# 251612
    • Ohio
      • Cincinnati, Ohio, United States, 45215-2123
        • Patient Priority Clinical Sites, LLC /ID# 250922
      • West Chester, Ohio, United States, 45069
        • CincyScience /ID# 250935
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Institute of Oklahoma City /ID# 250926
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Access Clinical Trials, Inc. /ID# 250914
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology /ID# 251613
      • El Paso, Texas, United States, 79925-7945
        • 3A Research - East El Paso /ID# 250909
      • Friendswood, Texas, United States, 77546
        • Earle Research /ID# 250908
      • The Woodlands, Texas, United States, 77381
        • Family Psychiatry of The Woodlands /ID# 250936
      • Waxahachie, Texas, United States, 75165-1430
        • ClinPoint Trials /ID# 250942
    • Utah
      • Bountiful, Utah, United States, 84010-4968
        • Pantheon Clinical Research /ID# 251615
      • Salt Lake City, Utah, United States, 84124
        • Highland Clinical Research /ID# 250924
    • Virginia
      • Franklin, Virginia, United States, 23851
        • Office of Maria Ona /ID# 250939
    • Washington
      • Everett, Washington, United States, 98201
        • Core Clinical Research /ID# 250932

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

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atogepant Dose A (12-17 yrs)
Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Atogepant Dose B (6-11 yrs)
Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AEs)
Time Frame: Up to 56 Weeks
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
Time Frame: Up to 52 Weeks
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)
Time Frame: Up to 52 Weeks
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
Time Frame: Up to 52 Weeks
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
Time Frame: Up to 52 Weeks
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)
Time Frame: Up to 52 Weeks
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
Time Frame: Baseline (Week 0) through Week 52
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
Time Frame: Baseline (Week 0) through Week 52
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

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.

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)

June 5, 2023

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 11, 2025

Last Update Submitted That Met QC Criteria

August 6, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-199
  • 2022-501099-24-00 (Other Identifier: EU CT)

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
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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