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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT05711394

Registry updated: 2026-10-06
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Description

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 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.

Interventions

  • Atogepant (Drug)
    Oral Tablet
  • Placebo-Matching Atogepant (Drug)
    Oral Tablet

Eligibility criteria

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 (consistent with a diagnosis according to the ICHD-3 \[2018\]) 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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Conditions

Episodic Migraine

Locations

  • Rehabilitation & Neurological Services /ID# 248517 — Huntsville, Alabama, United States
  • The Center for Clinical Trials - Saraland /ID# 271604 — Saraland, 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
  • FWD Clinical Research - 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 Childrens 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
  • Children's Hospital of Philadelphia - Main /ID# 258071 — Philadelphia, Pennsylvania, 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
  • Alpine Research Organization - Clinton /ID# 276497 — Clinton, 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
  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201 — Bruges, West-Vlaanderen, 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 Gesu /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 - Osaka /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 Medic-R /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 /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 Headlands /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, Bucharest, 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 de 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
  • Great Ormond Street Children's Hospital /ID# 262933 — London, Greater London, United Kingdom
  • Medway NHS Foundation Trust /ID# 249065 — Gillingham, Kent, United Kingdom
  • NHS Grampian /ID# 249067 — Aberdeen, United Kingdom
  • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121 — Stockport, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record