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Could a daily pill stop migraines in kids? new trial aims to find out

NCT ID NCT05711394

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 18 times

Summary

This phase 3 trial is testing atogepant, a daily pill already approved for adults, to prevent episodic migraines in children aged 6 to 17. About 450 participants will receive either a low or high dose of the drug or a placebo for 12 weeks. The goal is to see if it safely reduces the number of migraine days per month in young people.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
atogepant (QULIPTA)
What this could lead to
If successful, this could provide a new daily pill to prevent migraines in children and teens, reducing the number of migraine days per month.
What could go wrong
This is still an experimental use in children; the drug is already approved for adults but may work differently or cause side effects in younger patients. The trial is ongoing, so results are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Episodic migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    69 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 3A Research - East El Paso /ID# 248516

    COMPLETED

    El Paso, Texas, 79925-7945, United States

  • Aalborg Sygehus Nord /ID# 247428

    RECRUITING

    Aalborg, North Denmark, 9000, Denmark

  • Access Clinical Trials, Inc. /ID# 248532

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Advanced Neurosciences Research, LLC /ID# 247592

    COMPLETED

    Fort Collins, Colorado, 80528, United States

  • Advanced Research Center /ID# 251381

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami /ID# 248539

    COMPLETED

    Homestead, Florida, 33030-4613, United States

  • Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201

    RECRUITING

    Bruges, West-Vlaanderen, 8000, Belgium

  • Alliance for Research Alliance for Wellness /ID# 248521

    RECRUITING

    Long Beach, California, 90807, United States

  • Alpine Research Organization - Clinton /ID# 276497

    RECRUITING

    Clinton, Utah, 84015, United States

  • Athleticomed Sp. z o.o /ID# 248789

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638

    RECRUITING

    Palermo, 90127, Italy

  • Bnai Zion Medical Center /ID# 247469

    RECRUITING

    Haifa, 3339419, Israel

  • CHU Amiens-Picardie Site Sud /ID# 248833

    COMPLETED

    Amiens, Somme, 80054, France

  • CHU Toulouse - Hôpital des enfants /ID# 247553

    COMPLETED

    Toulouse, 31059, France

  • Canisius-Wilhelmina Ziekenhuis /ID# 253065

    RECRUITING

    Nijmegen, Gelderland, 6532 SZ, Netherlands

  • Caribbean Medical Research Center Headlands /ID# 251634

    RECRUITING

    San Juan, 00918-3501, Puerto Rico

  • Centre Hosp Intercommunal de Creteil /ID# 248832

    COMPLETED

    Créteil, Val-de-Marne, 94000, France

  • Children's Hospital of Philadelphia - Main /ID# 258071

    RECRUITING

    Philadelphia, Pennsylvania, 19104-4319, United States

  • Cincinnati Childrens Hospital Medical Center /ID# 258070

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • CincyScience /ID# 249726

    COMPLETED

    West Chester, Ohio, 45069, United States

  • ClinPoint Trials /ID# 248540

    RECRUITING

    Waxahachie, Texas, 75165-1430, United States

  • Clinical Research Center Medic-R /ID# 247383

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-848, Poland

  • Clinical Research Investigator Group /ID# 261254

    COMPLETED

    Bayamón, 00960, Puerto Rico

  • Coastal Georgia Child Neurology /ID# 249733

    RECRUITING

    Brunswick, Georgia, 31520-1601, United States

  • Cognitive Clinical Trials (CCT) - Papillion /ID# 248536

    COMPLETED

    Papillion, Nebraska, 68046-4131, United States

  • College Park Family Care Center Overland Park /ID# 249734

    COMPLETED

    Overland Park, Kansas, 66210-2761, United States

  • Core Clinical Research /ID# 249721

    COMPLETED

    Everett, Washington, 98201, United States

  • Deaconess Clinic - Gateway Health Center /ID# 247589

    RECRUITING

    Newburgh, Indiana, 47630, United States

  • Delta Health Care S.R.L /ID# 248130

    COMPLETED

    Bucharest, 014146, Romania

  • Dent Neurologic Institute - Amherst /ID# 248534

    RECRUITING

    Amherst, New York, 14226, United States

  • Dr. Samuel Sanchez PSC /ID# 248495

    COMPLETED

    Caguas, 00727, Puerto Rico

  • Earle Research /ID# 248501

    RECRUITING

    Friendswood, Texas, 77546, United States

  • Excell Research, Inc /ID# 247532

    COMPLETED

    Oceanside, California, 92056, United States

  • FWD Clinical Research - Spring Hill /ID# 248525

    COMPLETED

    Spring Hill, Florida, 34609-5692, United States

  • Family Psychiatry of The Woodlands /ID# 249727

    COMPLETED

    The Woodlands, Texas, 77381, United States

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581

    RECRUITING

    Milan, Milano, 20133, Italy

  • FutureSearch Trials of Neurology /ID# 247470

    COMPLETED

    Austin, Texas, 78731, United States

  • Goryeb Childrens Hospital /ID# 249724

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Great Ormond Street Children's Hospital /ID# 262933

    RECRUITING

    London, Greater London, WC1N 3HZ, United Kingdom

  • HagaZiekenhuis /ID# 247318

    RECRUITING

    The Hague, South Holland, 2545 AA, Netherlands

  • Headache Wellness Center /ID# 251018

    RECRUITING

    Greensboro, North Carolina, 27405, United States

  • Herlev Hospital /ID# 247724

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Highland Clinical Research /ID# 247590

    RECRUITING

    Salt Lake City, Utah, 84124, United States

  • Hillel Yaffe Medical Center /ID# 246747

    COMPLETED

    Hadera, Haifa District, 38100, Israel

  • Hospital Clinico San Carlos /ID# 249267

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario 12 de Octubre /ID# 275578

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Vall de Hebron /ID# 247967

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen del Rocio /ID# 248632

    COMPLETED

    Seville, 41013, Spain

  • Hospital Universitario y Politecnico La Fe /ID# 247969

    COMPLETED

    Valencia, 46026, Spain

  • Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382

    RECRUITING

    Lublin, Lublin Voivodeship, 20-582, Poland

  • Konan Medical Center /ID# 254457

    RECRUITING

    Kobe, Hyōgo, 658-0064, Japan

  • Le Bonheur Children's Hospital /ID# 261084

    COMPLETED

    Memphis, Tennessee, 38103, United States

  • London Health Sciences Center- University Hospital /ID# 252979

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Lumos Clinical Research Center /ID# 249731

    RECRUITING

    San Jose, California, 95124-4108, United States

  • Lynn Institute of Oklahoma City /ID# 247600

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381

    RECRUITING

    Wroclaw, 52-210, Poland

  • MIND Clinic /ID# 248687

    COMPLETED

    Budapest, 1024, Hungary

  • McGill University Health Centre - Glen Site /ID# 247271

    COMPLETED

    Montreal, Quebec, H4A 3J1, Canada

  • Medway NHS Foundation Trust /ID# 249065

    RECRUITING

    Gillingham, Kent, ME7 5NY, United Kingdom

  • Michigan Headache & Neurological Institute (MHNI) /ID# 247468

    RECRUITING

    Ann Arbor, Michigan, 48104-5131, United States

  • Modern Migraine MD /ID# 258074

    COMPLETED

    New York, New York, 10001, United States

  • My Preferred Research LLC /ID# 249720

    RECRUITING

    Miami, Florida, 33155, United States

  • NHS Grampian /ID# 249067

    RECRUITING

    Aberdeen, AB15 6RE, United Kingdom

  • Northwest Florida Clinical Research Group, LLC /ID# 251382

    COMPLETED

    Gulf Breeze, Florida, 32561-4495, United States

  • Office of Maria Ona /ID# 249738

    RECRUITING

    Franklin, Virginia, 23851, United States

  • Oha-Med Sp. Z O.O /ID# 248614

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-018, Poland

  • Ospedale Pediatrico Bambino Gesu /ID# 247647

    RECRUITING

    Rome, Roma, 00165, Italy

  • PRCCI Clinical Research Center /ID# 262726

    COMPLETED

    San Juan, 00927, Puerto Rico

  • Pantheon Clinical Research /ID# 251601

    RECRUITING

    Bountiful, Utah, 84010-4968, United States

  • Patient Priority Clinical Sites, LLC /ID# 247535

    RECRUITING

    Cincinnati, Ohio, 45215-2123, United States

  • Preferred Research Partners /ID# 249729

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Preferred Research Partners /ID# 270406

    COMPLETED

    Little Rock, Arkansas, 72211, United States

  • Proven Endpoints LLC /ID# 258066

    RECRUITING

    Ridgeland, Mississippi, 39157, United States

  • Puerto Rico Health Institute /ID# 249741

    RECRUITING

    Dorado, 00646, Puerto Rico

  • Regionshospitalet Godstrup /ID# 247902

    RECRUITING

    Herning, Central Jutland, 7400, Denmark

  • Rehabilitation & Neurological Services /ID# 248517

    RECRUITING

    Huntsville, Alabama, 35805-4046, United States

  • Semmelweis Egyetem /ID# 248360

    RECRUITING

    Budapest, 1085, Hungary

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211

    RECRUITING

    Sendai, Miyagi, 982-0014, Japan

  • Shamir Medical Center /ID# 256857

    RECRUITING

    Beer Ya'akov, Central District, 70300, Israel

  • Sodersjukhuset /ID# 248279

    RECRUITING

    Stockholm, Stockholm County, 118 83, Sweden

  • Specjalistyczne Gabinety Sp. z o.o. /ID# 247384

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-539, Poland

  • Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431

    COMPLETED

    Bucharest, Bucharest, 022102, Romania

  • Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595

    COMPLETED

    Cluj-Napoca, Cluj, 400012, Romania

  • Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121

    RECRUITING

    Stockport, SK2 7JE, United Kingdom

  • Stollery Children's Hospital /ID# 249672

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Sunwise Clinical Research /ID# 248529

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Tatsuoka Neurology Clinic /ID# 254455

    RECRUITING

    Kyoto, 600-8811, Japan

  • Tel Aviv Sourasky Medical Center /ID# 247466

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Center for Clinical Trials - Saraland /ID# 271604

    RECRUITING

    Saraland, Alabama, 36571, United States

  • The Chaim Sheba Medical Center /ID# 246746

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Tokyo Medical University Hospital /ID# 254459

    RECRUITING

    Shinjuku-ku, Tokyo, 160-0023, Japan

  • Tominaga Clinic - Osaka /ID# 254450

    RECRUITING

    Osaka, Osaka, 556-0015, Japan

  • UT Health Austin at Dell Children's Neurology Clinic /ID# 264082

    RECRUITING

    Austin, Texas, 78723-3079, United States

  • Umenotsuji Clinic /ID# 254453

    RECRUITING

    Kochi, Kochi, 780-8011, Japan

  • Uza /Id# 247339

    RECRUITING

    Edegem, Antwerpen, 2650, Belgium

  • Vastra Gotealandsregionen Regionhalsan /ID# 248277

    RECRUITING

    Mölnlycke, 435 30, Sweden

  • Yamaguchi Clinic /ID# 254753

    RECRUITING

    Nishinomiya, Hyōgo, 663-8204, Japan

  • ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301

    RECRUITING

    Terneuzen, Zeeland, 4535 PA, Netherlands

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