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.
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
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
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
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
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
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
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
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
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
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
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
Belgium2 sites
AZ Sint-Jan Brugge /ID# 247527
Bruges, 8000
Uza /Id# 247885
Edegem, Antwerpen, 2650
Canada2 sites
Stollery Children's Hospital /ID# 251426
Edmonton, Alberta, T6G 2B7
Montreal Children's Hospital /ID# 250649
Montreal, Quebec, H4A 3J1
Hungary2 sites
Semmelweis Egyetem /ID# 251593
Budapest, Budapest, 1085
Mind Klinika Kft. /ID# 251597
Budapest, 1024
Italy2 sites
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182
Milan, Milano, 20133
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184
Palermo, Palermo, 90127
Sweden2 sites
Vastra Gotealandsregionen Regionhalsan /ID# 248981
Mölnlycke, 435 30
Sodersjukhuset /ID# 250671
Stockholm, 118 83
United Kingdom2 sites
NHS Grampian /ID# 251474
Aberdeen, AB15 6RE
Stockport NHS foundation trust /ID# 261562
Stockport, SK2 7JE
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.
- Conditions
- Migraine Prophylaxis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atogepant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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.
- First posted1 Feb 2023
- Study start5 Jun 2023
- Primary completionApr 2032 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine ProphylaxisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
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.