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Migraine ProphylaxisPhase 3KaleidoscopeNCT05707949

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

A Phase 3 study testing Atogepant in people with Migraine Prophylaxis, run by AbbVie at 86 sites in 16 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Migraine Prophylaxis
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
86 sitesin 16 countries
Study dates
5 Jun 2023to Apr 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

86 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

86 sites in 16 countries

United States35 sites

  • Dent Neurosciences Research Center, Inc. /ID# 250915

    Amherst, New York, 14226

  • Advanced Research Center /ID# 251616

    Anaheim, California, 92805

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

    Ann Arbor, Michigan, 48104-5131

  • FutureSearch Trials of Neurology /ID# 251613

    Austin, Texas, 78731

  • Pantheon Clinical Research /ID# 251615

    Bountiful, Utah, 84010-4968

  • Coastal Georgia Child Neurology /ID# 250938

    Brunswick, Georgia, 31520-1601

  • Patient Priority Clinical Sites, LLC /ID# 250922

    Cincinnati, Ohio, 45215-2123

  • 3A Research - East El Paso /ID# 250909

    El Paso, Texas, 79925-7945

  • Core Clinical Research /ID# 250932

    Everett, Washington, 98201

  • Advanced Neurosciences Research, LLC /ID# 250925

    Fort Collins, Colorado, 80528

  • Office of Maria Ona /ID# 250939

    Franklin, Virginia, 23851

  • Earle Research /ID# 250908

    Friendswood, Texas, 77546

  • Headache Wellness Center /ID# 251612

    Greensboro, North Carolina, 27405

  • Northwest Florida Clinical Research Group, LLC /ID# 251614

    Gulf Breeze, Florida, 32561-4495

  • Advanced Research Institute of Miami /ID# 250916

    Homestead, Florida, 33030-4613

  • Rehabilitation & Neurological Services /ID# 250910

    Huntsville, Alabama, 35805-4046

  • Sunwise Clinical Research /ID# 250913

    Lafayette, California, 94549-4579

  • Preferred Research Partners /ID# 250937

    Little Rock, Arkansas, 72211

  • Alliance for Research Alliance for Wellness /ID# 250911

    Long Beach, California, 90807

  • My Preferred Research LLC /ID# 250931

    Miami, Florida, 33155

  • Goryeb Children's Hospital /ID# 250934

    Morristown, New Jersey, 07960

  • Access Clinical Trials, Inc. /ID# 250914

    Nashville, Tennessee, 37203

  • Modern Migraine MD /ID# 258082

    New York, New York, 10001

  • Deaconess Clinic - Gateway Health Center /ID# 250923

    Newburgh, Indiana, 47630

  • Excell Research, Inc /ID# 251611

    Oceanside, California, 92056

  • Lynn Institute of Oklahoma City /ID# 250926

    Oklahoma City, Oklahoma, 73112

  • College Park Family Care Center Overland Park /ID# 251609

    Overland Park, Kansas, 66210-2761

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

    Papillion, Nebraska, 68046-4131

  • Proven Endpoints LLC /ID# 258083

    Ridgeland, Mississippi, 39157

  • Highland Clinical Research /ID# 250924

    Salt Lake City, Utah, 84124

  • Lumos Clinical Research Center /ID# 251608

    San Jose, California, 95124-4108

  • Asclepes Research Centers - Spring Hill /ID# 250912

    Spring Hill, Florida, 34609-5692

  • Family Psychiatry of The Woodlands /ID# 250936

    The Woodlands, Texas, 77381

  • ClinPoint Trials /ID# 250942

    Waxahachie, Texas, 75165-1430

  • CincyScience /ID# 250935

    West Chester, Ohio, 45069

Other trials in United States

Japan7 sites

  • Konan Medical Center /ID# 254458

    Kobe, Hyōgo, 658-0064

  • Umenotsuji Clinic /ID# 254454

    Kochi, Kochi, 780-8011

  • Tatsuoka Neurology Clinic /ID# 254456

    Kyoto, 600-8811

  • Yamaguchi Clinic /ID# 254763

    Nishinomiya-shi, Hyōgo, 663-8204

  • Tominaga Clinic /ID# 254451

    Osaka, Osaka, 5560015

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212

    Sendai, Miyagi, 982-0014

  • Tokyo Medical University Hospital /ID# 254460

    Shinjuku-ku, Tokyo, 160-0023

Other trials in Japan

Poland6 sites

  • Athleticomed Sp. z o.o /ID# 250620

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

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

    Krakow, Lesser Poland Voivodeship, 30-539

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

    Lublin, Lublin Voivodeship, 20-582

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

    Poznan, Greater Poland Voivodeship, 61-731

  • OHA-MED sp. z o.o /ID# 250621

    Warsaw, Masovian Voivodeship, 00-414

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

    Wroclaw, 52-210

Other trials in Poland

Israel5 sites

  • Shamir Medical Center /ID# 256858

    Beer Ya'akov, Central District, 70300

  • Hillel Yaffe Medical Center /ID# 248923

    Hadera, H_efa, 38100

  • Bnai Zion Medical Center /ID# 251132

    Haifa, H_efa, 3339419

  • The Chaim Sheba Medical Center /ID# 248990

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 251133

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Puerto Rico5 sites

  • Clinical Research Investigator Group, LLC /ID# 261251

    Bayamón, Puerto Rico, 00960

  • Dr. Samuel Sanchez PSC /ID# 261670

    Caguas, Puerto Rico, 00727

  • Puerto Rico Health Institute /ID# 250949

    Dorado, Puerto Rico, 00646

  • Caribbean Medical Research Center /ID# 253156

    San Juan, Puerto Rico, 00918-3501

  • PRCCI Clinical Research Center /ID# 264232

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

Spain4 sites

  • Hospital Universitario Vall d'Hebron /ID# 248457

    Barcelona, Barcelona, 08035

  • Hospital Clinico San Carlos /ID# 249268

    Madrid, Madrid, 28040

  • Hospital Universitario Virgen del Rocio /ID# 248633

    Seville, Sevilla, 41013

  • Hospital Universitario y Politecnico La Fe /ID# 248459

    Valencia, Valencia, 46026

Other trials in Spain

Denmark3 sites

  • Aalborg Universitetshospital /Id# 247429

    Aalborg, North Denmark, 9000

  • Herlev Hospital /ID# 247725

    Herlev, Capital Region, 2730

  • Regionshospitalet Godstrup /ID# 247903

    Herning, Central Jutland, 7400

Other trials in Denmark

France3 sites

  • CHU Amiens-Picardie Site Sud /ID# 251377

    Amiens, Somme, 80054

  • Centre Hosp Intercommunal de Creteil /ID# 251199

    Créteil, Val-de-Marne, 94000

  • CHU Toulouse - Hôpital des enfants /ID# 251201

    Toulouse, 31059

Other trials in France

Netherlands3 sites

  • Canisius-Wilhelmina Ziekenhuis /ID# 253067

    Nijmegen, 6532 SZ

  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603

    Terneuzen, 4535 PA

  • HagaZiekenhuis /ID# 251655

    The Hague, 2545 AA

Other trials in Netherlands

Romania3 sites

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

    Bucharest, Bucharest, 022102

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

    Bucharest, 014146

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

    Cluj-Napoca, Cluj, 400012

Other trials in Romania

Belgium2 sites

  • AZ Sint-Jan Brugge /ID# 247527

    Bruges, 8000

  • Uza /Id# 247885

    Edegem, Antwerpen, 2650

Other trials in Belgium

Canada2 sites

  • Stollery Children's Hospital /ID# 251426

    Edmonton, Alberta, T6G 2B7

  • Montreal Children's Hospital /ID# 250649

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Hungary2 sites

  • Semmelweis Egyetem /ID# 251593

    Budapest, Budapest, 1085

  • Mind Klinika Kft. /ID# 251597

    Budapest, 1024

Other trials in Hungary

Italy2 sites

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182

    Milan, Milano, 20133

  • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184

    Palermo, Palermo, 90127

Other trials in Italy

Sweden2 sites

  • Vastra Gotealandsregionen Regionhalsan /ID# 248981

    Mölnlycke, 435 30

  • Sodersjukhuset /ID# 250671

    Stockholm, 118 83

Other trials in Sweden

United Kingdom2 sites

  • NHS Grampian /ID# 251474

    Aberdeen, AB15 6RE

  • Stockport NHS foundation trust /ID# 261562

    Stockport, SK2 7JE

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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.

Being tested
Atogepant
Keywords
Migraine Prophylaxis, Atogepant, QULIPTA, AGN-241689

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called QULIPTA, AGN-241689

    Oral Tablet

Study groups in NCT05707949
Study groupRoleWhat they receive
Atogepant Dose A (12-17 yrs)ExperimentalParticipant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Receives: Drug: Atogepant
Atogepant Dose B (6-11 yrs)ExperimentalParticipants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.
Receives: Drug: Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 56 Weeks

  2. 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.

    Measured: Up to 52 Weeks

  3. 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).

    Measured: Up to 52 Weeks

  4. 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.

    Measured: Up to 52 Weeks

  5. 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).

    Measured: Up to 52 Weeks

  6. 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.

    Measured: Up to 52 Weeks

  7. Change from Baseline in Tanner Staging Score

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

    Measured: Baseline (Week 0) through Week 52

  8. 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

    Measured: Baseline (Week 0) through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2023
  2. Study start5 Jun 2023
  3. Primary completionApr 2032 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05707949
Sponsor's protocol ID
M21-199
Other IDs
2022-501099-24-00
Acronym
Kaleidoscope
Status last verified
Aug 2025
First submitted
24 Jan 2023
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Migraine Prophylaxis, run by AbbVie at 86 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Japan, Poland, Israel, Puerto Rico and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AEs) (time frame: Up to 56 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05707949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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