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
NCT ID: NCT05711394
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2023-05-01
2028-05-31
Brief Summary
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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 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 worldwide.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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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.
Atogepant
Oral Tablet
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.
Atogepant
Oral Tablet
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.
Atogepant
Oral Tablet
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.
Placebo-Matching Atogepant
Oral Tablet
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.
Atogepant
Oral Tablet
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.
Atogepant
Oral Tablet
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.
Placebo-Matching Atogepant
Oral Tablet
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.
Atogepant
Oral Tablet
Interventions
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Atogepant
Oral Tablet
Placebo-Matching Atogepant
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.
Exclusion Criteria
* Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
* 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).
6 Years
17 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Rehabilitation & Neurological Services /ID# 248517
Huntsville, Alabama, United States
Preferred Research Partners /ID# 249729
Little Rock, Arkansas, United States
Preferred Research Partners /ID# 270406
Little Rock, Arkansas, United States
Advanced Research Center /ID# 251381
Anaheim, California, United States
Alliance for Research Alliance for Wellness /ID# 248521
Long Beach, California, United States
Excell Research, Inc /ID# 247532
Oceanside, California, United States
Lumos Clinical Research Center /ID# 249731
San Jose, California, United States
Sunwise Clinical Research /ID# 248529
Walnut Creek, California, United States
Advanced Neurosciences Research, LLC /ID# 247592
Fort Collins, Colorado, United States
Northwest Florida Clinical Research Group, LLC /ID# 251382
Gulf Breeze, Florida, United States
Advanced Research Institute of Miami /ID# 248539
Homestead, Florida, United States
My Preferred Research LLC /ID# 249720
Miami, Florida, United States
Asclepes Research Centers - Spring Hill /ID# 248525
Spring Hill, Florida, United States
Coastal Georgia Child Neurology /ID# 249733
Brunswick, Georgia, United States
Deaconess Clinic - Gateway Health Center /ID# 247589
Newburgh, Indiana, United States
College Park Family Care Center Overland Park /ID# 249734
Overland Park, Kansas, United States
Michigan Headache & Neurological Institute (MHNI) /ID# 247468
Ann Arbor, Michigan, United States
Proven Endpoints LLC /ID# 258066
Ridgeland, Mississippi, United States
Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
Papillion, Nebraska, United States
Goryeb Children's Hospital /ID# 249724
Morristown, New Jersey, United States
Dent Neurologic Institute - Amherst /ID# 248534
Amherst, New York, United States
Modern Migraine MD /ID# 258074
New York, New York, United States
Headache Wellness Center /ID# 251018
Greensboro, North Carolina, United States
Patient Priority Clinical Sites, LLC /ID# 247535
Cincinnati, Ohio, United States
Cincinnati Childrens Hospital Medical Center /ID# 258070
Cincinnati, Ohio, United States
CincyScience /ID# 249726
West Chester, Ohio, United States
Lynn Institute of Oklahoma City /ID# 247600
Oklahoma City, Oklahoma, United States
Le Bonheur Children's Hospital /ID# 261084
Memphis, Tennessee, United States
Access Clinical Trials, Inc. /ID# 248532
Nashville, Tennessee, United States
UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
Austin, Texas, United States
FutureSearch Trials of Neurology /ID# 247470
Austin, Texas, United States
3A Research - East El Paso /ID# 248516
El Paso, Texas, United States
Earle Research /ID# 248501
Friendswood, Texas, United States
Family Psychiatry of The Woodlands /ID# 249727
The Woodlands, Texas, United States
ClinPoint Trials /ID# 248540
Waxahachie, Texas, United States
Pantheon Clinical Research /ID# 251601
Bountiful, Utah, United States
Highland Clinical Research /ID# 247590
Salt Lake City, Utah, United States
Office of Maria Ona /ID# 249738
Franklin, Virginia, United States
Core Clinical Research /ID# 249721
Everett, Washington, United States
Uza /Id# 247339
Edegem, Antwerpen, Belgium
AZ Sint-Jan Brugge /ID# 247201
Bruges, , Belgium
Stollery Children's Hospital /ID# 249672
Edmonton, Alberta, Canada
London Health Sciences Center- University Hospital /ID# 252979
London, Ontario, Canada
McGill University Health Centre - Glen Site /ID# 247271
Montreal, Quebec, Canada
Herlev Hospital /ID# 247724
Herlev, Capital Region, Denmark
Regionshospitalet Godstrup /ID# 247902
Herning, Central Jutland, Denmark
Aalborg Sygehus Nord /ID# 247428
Aalborg, North Denmark, Denmark
CHU Amiens-Picardie Site Sud /ID# 248833
Amiens, Somme, France
Centre Hosp Intercommunal de Creteil /ID# 248832
Créteil, Val-de-Marne, France
CHU Toulouse - Hôpital des enfants /ID# 247553
Toulouse, , France
MIND Clinic /ID# 248687
Budapest, , Hungary
Semmelweis Egyetem /ID# 248360
Budapest, , Hungary
Shamir Medical Center /ID# 256857
Beer Ya'akov, Central District, Israel
Hillel Yaffe Medical Center /ID# 246747
Hadera, Haifa District, Israel
The Chaim Sheba Medical Center /ID# 246746
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 247466
Tel Aviv, Tel Aviv, Israel
Bnai Zion Medical Center /ID# 247469
Haifa, , Israel
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
Milan, Milano, Italy
Ospedale Pediatrico Bambino Gesù /ID# 247647
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
Palermo, , Italy
Konan Medical Center /ID# 254457
Kobe, Hyōgo, Japan
Yamaguchi Clinic /ID# 254753
Nishinomiya, Hyōgo, Japan
Umenotsuji Clinic /ID# 254453
Kochi, Kochi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
Sendai, Miyagi, Japan
Tominaga Clinic /ID# 254450
Osaka, Osaka, Japan
Tokyo Medical University Hospital /ID# 254459
Shinjuku-ku, Tokyo, Japan
Tatsuoka Neurology Clinic /ID# 254455
Kyoto, , Japan
Canisius-Wilhelmina Ziekenhuis /ID# 253065
Nijmegen, Gelderland, Netherlands
HagaZiekenhuis /ID# 247318
The Hague, South Holland, Netherlands
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
Terneuzen, Zeeland, Netherlands
Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247383
Poznan, Greater Poland Voivodeship, Poland
Athleticomed Sp. z o.o /ID# 248789
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
Krakow, Lesser Poland Voivodeship, Poland
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
Lublin, Lublin Voivodeship, Poland
OHA-MED sp. z o.o /ID# 248614
Warsaw, Masovian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
Wroclaw, , Poland
Clinical Research Investigator Group, LLC /ID# 261254
Bayamón, , Puerto Rico
Dr. Samuel Sanchez PSC /ID# 248495
Caguas, , Puerto Rico
Puerto Rico Health Institute /ID# 249741
Dorado, , Puerto Rico
Caribbean Medical Research Center /ID# 251634
San Juan, , Puerto Rico
PRCCI Clinical Research Center /ID# 262726
San Juan, , Puerto Rico
Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
Bucharest, București, Romania
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
Cluj-Napoca, Cluj, Romania
Delta Health Care S.R.L /ID# 248130
Bucharest, , Romania
Hospital Universitario Vall d'Hebron /ID# 247967
Barcelona, , Spain
Hospital Clinico San Carlos /ID# 249267
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 275578
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 248632
Seville, , Spain
Hospital Universitario y Politecnico La Fe /ID# 247969
Valencia, , Spain
Sodersjukhuset /ID# 248279
Stockholm, Stockholm County, Sweden
Vastra Gotealandsregionen Regionhalsan /ID# 248277
Mölnlycke, , Sweden
Medway NHS Foundation Trust /ID# 249065
Gillingham, Kent, United Kingdom
NHS Grampian /ID# 249067
Aberdeen, , United Kingdom
Stockport NHS foundation trust /ID# 261121
Stockport, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Site Coordinator
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Related Links
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Other Identifiers
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2022-501100-94-00
Identifier Type: OTHER
Identifier Source: secondary_id
M21-201
Identifier Type: -
Identifier Source: org_study_id
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