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 (Kaleidoscope)

April 9, 2024 updated by: AbbVie

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

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 episodic 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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

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 Contact

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • Recruiting
        • AZ Sint-Jan Brugge /ID# 247201
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Uza /Id# 247339
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Stollery Children's Hospital /ID# 249672
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Montreal Children's Hospital /ID# 247271
  • Denmark
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Recruiting
        • Herlev and Gentofte Hospital /ID# 247724
        • Contact:
          • Site Coordinator
          • Phone Number: +45 38 68 51 28
    • Midtjylland
      • Herning, Midtjylland, Denmark, 7400
        • Recruiting
        • Regionshospitalet Godstrup /ID# 247902
        • Contact:
          • Site Coordinator
          • Phone Number: +45 50935730
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital /Id# 247428
  • France
      • Toulouse CEDEX 9, France, 31059
        • Recruiting
        • CHU Toulouse - Hôpital des enfants /ID# 247553
    • Val-de-Marne
      • Creteil, Val-de-Marne, France, 94000
        • Recruiting
        • Centre Hosp Intercommunal de Creteil /ID# 248832
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem /ID# 248360
      • Budapest, Hungary, 1024
        • Recruiting
        • Mind Klinika Kft. /ID# 248687
  • Israel
    • H_efa
      • Hadera, H_efa, Israel, 38100
        • Recruiting
        • Hillel Yaffe Medical Center /ID# 246747
      • Haifa, H_efa, Israel, 3339419
        • Recruiting
        • Bnai Zion Medical Center /ID# 247469
    • HaMerkaz
      • Be'er Yaakov, HaMerkaz, Israel, 70300
        • Recruiting
        • Shamir Medical Center (Assaf Harofeh) /ID# 256857
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 246746
      • Tel Aviv, Tel-Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 247466
  • Italy
      • Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
      • Palermo, Italy, 90127
        • Recruiting
        • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 247638
  • Japan
      • Kyoto, Japan, 600-8811
        • Recruiting
        • Tatsuoka Neurology Clinic /ID# 254455
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center /ID# 254457
      • Nishinomiya, Hyogo, Japan, 663-8204
        • Recruiting
        • Yamaguchi Clinic /ID# 254753
    • Kochi
      • Kochi-shi, Kochi, Japan, 780-8011
        • Recruiting
        • Umenotsuji Clinic /ID# 254453
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
    • Osaka
      • Osaka-shi, Osaka, Japan, 5560015
        • Recruiting
        • Tominaga Clinic /ID# 254450
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 254459
  • Netherlands
      • Den Haag, Netherlands, 2545 AA
        • Recruiting
        • HagaZiekenhuis /ID# 247318
      • Nijmegen, Netherlands, 6532 SZ
        • Recruiting
        • Canisius-Wilhelmina Ziekenhuis /ID# 253065
      • Terneuzen, Netherlands, 4535 PA
        • Recruiting
        • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
  • Poland
      • Bydgoszcz, Poland, 85-752
        • Recruiting
        • Athleticomed Sp. z o.o /ID# 248789
      • Wroclaw, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Recruiting
        • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-539
        • Recruiting
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 00-414
        • Recruiting
        • OHA-MED sp. z o.o /ID# 248614
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247383
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute /ID# 249741
        • Contact:
          • Site Coordinator
          • Phone Number: 787-797-1049
      • San Juan, Puerto Rico, 00918-3501
        • Recruiting
        • Caribbean Medical Research Center /ID# 251634
  • Romania
      • Bucharest, Romania, 014146
        • Recruiting
        • Delta Health Care S.R.L /ID# 248130
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 022102
        • Recruiting
        • Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400012
        • Recruiting
        • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron /ID# 247967
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico Universitario San Carlos /ID# 249267
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio /ID# 248632
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politecnico La Fe /ID# 247969
  • Sweden
      • Molnlycke, Sweden, 435 30
        • Recruiting
        • Vastra Gotealandsregionen Regionhalsan /ID# 248277
      • Stockholm, Sweden, 118 83
        • Recruiting
        • Sodersjukhuset /ID# 248279
  • United Kingdom
      • Aberdeen, United Kingdom, AB15 6RE
        • Recruiting
        • NHS Grampian /ID# 249067
      • Stockport, United Kingdom, SK2 7JE
        • Recruiting
        • Stockport NHS foundation trust /ID# 261121
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805-4046
        • Recruiting
        • Rehabilitation & Neurological Services /ID# 248517
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners /ID# 249729
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center /ID# 251381
      • Lafayette, California, United States, 94549-4579
        • Recruiting
        • Sunwise Clinical Research /ID# 248529
      • Long Beach, California, United States, 90807
        • Recruiting
        • Alliance for Research - Long Beach /ID# 248521
      • Oceanside, California, United States, 92056
        • Recruiting
        • Excell Research, Inc /ID# 247532
        • Contact:
          • Site Coordinator
          • Phone Number: 760-758-2222
      • San Jose, California, United States, 95124-4108
        • Recruiting
        • Lumos Clinical Research Center /ID# 249731
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Advanced Neurosciences Research, LLC /ID# 247592
    • Florida
      • Gulf Breeze, Florida, United States, 32561-4495
        • Recruiting
        • Northwest Florida Clinical Research Group, LLC /ID# 251382
        • Contact:
          • Site Coordinator
          • Phone Number: 850.934.1299
      • Homestead, Florida, United States, 33030-4613
        • Recruiting
        • Advanced Research Institute of Miami /ID# 248539
        • Contact:
          • Site Coordinator
          • Phone Number: 305-246-0001
      • Miami, Florida, United States, 33155
        • Recruiting
        • My Preferred Research LLC /ID# 249720
      • Spring Hill, Florida, United States, 34609-5692
        • Recruiting
        • Asclepes Research Centers - Spring Hill /ID# 248525
        • Contact:
          • Site Coordinator
          • Phone Number: 352-364-9401
    • Georgia
      • Brunswick, Georgia, United States, 31520-1601
        • Recruiting
        • Coastal Georgia Child Neurology /ID# 249733
        • Contact:
          • Site Coordinator
          • Phone Number: 770-376-7912
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Recruiting
        • Deaconess Clinic - Gateway Health Center /ID# 247589
        • Contact:
          • Site Coordinator
          • Phone Number: 812-474-7184
    • Kansas
      • Overland Park, Kansas, United States, 66210-2761
        • Recruiting
        • College Park Family Care Center Overland Park /ID# 249734
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5131
        • Recruiting
        • Michigan Headache & Neurological Institute (MHNI) /ID# 247468
        • Contact:
          • Site Coordinator
          • Phone Number: 734-677-6000
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Recruiting
        • Proven Endpoints LLC /ID# 258066
        • Contact:
          • Site Coordinator
          • Phone Number: 601-790-1811
    • Nebraska
      • Papillion, Nebraska, United States, 68046-4131
        • Recruiting
        • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
        • Contact:
          • Site Coordinator
          • Phone Number: 402-979-8770
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Children's Hospital /ID# 249724
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurosciences Research Center, Inc. /ID# 248534
        • Contact:
          • Site Coordinator
          • Phone Number: 716-558-5670
      • New York, New York, United States, 10001
        • Recruiting
        • Modern Migraine MD /ID# 258074
        • Contact:
          • Site Coordinator
          • Phone Number: 908-330-8549
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Headache Wellness Center /ID# 251018
    • Ohio
      • Cincinnati, Ohio, United States, 45215-2123
        • Recruiting
        • Patient Priority Clinical Sites, LLC /ID# 247535
        • Contact:
          • Site Coordinator
          • Phone Number: 513-791-7760
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • CincyScience /ID# 249726
        • Contact:
          • Site Coordinator
          • Phone Number: 513-229-7585
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Lynn Institute of Oklahoma City /ID# 247600
        • Contact:
          • Site Coordinator
          • Phone Number: 405-447-8839
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Access Clinical Trials, Inc. /ID# 248532
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • FutureSearch Trials of Neurology /ID# 247470
      • El Paso, Texas, United States, 79925-7945
        • Recruiting
        • 3A Research - East El Paso /ID# 248516
        • Contact:
          • Site Coordinator
          • Phone Number: 915-598-8888
      • Friendswood, Texas, United States, 77546
        • Recruiting
        • Earle Research /ID# 248501
        • Contact:
          • Site Coordinator
          • Phone Number: 281-218-8080
      • The Woodlands, Texas, United States, 77381
        • Recruiting
        • Family Psychiatry of The Woodlands /ID# 249727
      • Waxahachie, Texas, United States, 75165-1430
        • Recruiting
        • ClinPoint Trials /ID# 248540
    • Utah
      • Bountiful, Utah, United States, 84010-4968
        • Recruiting
        • Pantheon Clinical Research /ID# 251601
        • Contact:
          • Site Coordinator
          • Phone Number: 385-281-8351
      • Salt Lake City, Utah, United States, 84124
        • Recruiting
        • Highland Clinical Research /ID# 247590
    • Virginia
      • Franklin, Virginia, United States, 23851
        • Recruiting
        • Office of Maria Ona /ID# 249738
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research /ID# 249721

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:

  • 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 and per investigator judgment is appropriate to receive preventive treatment for migraine.

Exclusion Criteria:

  • 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 persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
  • Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.

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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
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
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
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
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: Placebo (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Drug: Placebo-Matching Atogepant
Oral Tablet
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA
Experimental: Double-Blind Treatment Period: Placebo (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Drug: Placebo-Matching Atogepant
Oral Tablet
Experimental: Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Drug: Atogepant
Oral Tablet
Other Names:
  • AGN-241689
  • QULIPTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mean Monthly Migraine Days
Time Frame: Baseline (Week 0) through Week 12
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Mean Monthly Headache Days
Time Frame: Baseline (Week 0) through Week 12
A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication (e.g., ibuprofen, triptan) was used after the start of the headache, in which case no minimum duration will be specified. Calendar days begin at midnight and last until 11:59 PM.
Baseline (Week 0) through Week 12
Change from Baseline in Mean Monthly Acute Medication Use Days
Time Frame: Baseline (Week 0) through Week 12
An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.
Baseline (Week 0) through Week 12
Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days
Time Frame: Baseline (Week 0) to 3 Months
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) to 3 Months
Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
Time Frame: Baseline (Week 0) through Week 12
The PedsQL is a 23-item measure that evaluates quality of life in four areas of functioning: physical, emotional, social, and school functioning. The PedsQL yields a total quality of life score and two summary scores: Physical Health Summary Score and Psychosocial Health Summary Score.
Baseline (Week 0) through Week 12
Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score
Time Frame: Baseline (Week 0) through Week 12
The PedMIDAS scale evaluates the impact of headache on school performance, disability at home and social/sport function. The score is a composite of the total of 6 questions.
Baseline (Week 0) through Week 12

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)

May 1, 2023

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

May 4, 2028

Study Registration Dates

First Submitted

January 26, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M21-201
  • 2022-501100-94-00 (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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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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