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New daily pill could stop menstrual migraines before they start

NCT ID NCT06806293

Prevention Sponsor: AbbVie Source: ClinicalTrials.gov ↗

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Recruiting now
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 This study
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 Results may not be published yet.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)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study tests a new medicine called atogepant to prevent migraines that happen around a woman's period. About 430 adult women with regular cycles and a history of migraines will take either atogepant or a placebo daily for 3 menstrual cycles. The goal is to see if the drug reduces the number of migraine days during that time.

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

468 people

The number who actually took part.

Started

Feb 2025

Expected to finish

Jul 2027

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

18 years and older

Sex

Female participants only

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: * History and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses). * History of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) for \>= 12 months prior to Visit 1/Screening. * Migraine onset before age 50 years. * By history at Visit 1/Screening, participant meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinion of the investigator. * Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the participant experiences and records a migraine attack in the eDiary with at least 1 migraine day. Exclusion Criteria: * History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by International Classification of Headache Disorders, 3rd Edition (ICHD-3). * An average of 15 or more headache days per month recorded in the eDiary during the screening period. * History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3. * Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3. * Required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening. * Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment. * Has a condition or situation, which the investigator feels will compromise the safety of the participant or the quality of the data and renders the subject an unsuitable candidate for the study.

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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.

Menstrual migraine (MM)

Contacts and locations

Locations

  • 2CA-Braga, Hospital de Braga /ID# 276218

    Braga, 4710-243, Portugal

  • A-Shine s.r.o. /ID# 266048

    Pilsen, Plzeň Region, 301 00, Czechia

  • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019

    Udine, 33100, Italy

  • Ambenet Hausarztpraxis /ID# 267309

    Leipzig, Saxony, 04107, Germany

  • Athleticomed Sp. z o.o /ID# 266434

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

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926

    Perugia, 06156, Italy

  • Azienda Ospedaliero Universitaria Careggi /ID# 276163

    Florence, Firenze, 50134, Italy

  • Azienda Ospedaliero Universitaria Luigi Vanvitelli/ID#267023

    Naples, Napoli, 80138, Italy

  • Breckland Alliance /ID# 268772

    Thetford, Norfolk, IP24 1JD, United Kingdom

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310

    Berlin, 10117, Germany

  • Chibune General Hospital /ID# 266874

    Osaka, Osaka, 555-0034, Japan

  • China Medical University Hospital /ID# 266423

    Taichung, 40447, Taiwan

  • Chinese PLA General Hospital /ID# 267141

    Beijing, Beijing Municipality, 100039, China

  • Clinexpert Kft /ID# 266644

    Budapest, 1033, Hungary

  • Clintrial s.r.o. /ID# 266047

    Prague, 100 00, Czechia

  • Cortex Study Center /ID# 266639

    Budapest, 1026, Hungary

  • DADO MEDICAL s.r.o. /ID# 267629

    Prague, Praha 2, 120 00, Czechia

  • Fakultni Thomayerova nemocnice /ID# 266049

    Prague, 140 59, Czechia

  • First Affiliated Hospital of Shanxi Medical University /ID# 267680

    Taiyuan, Shanxi, 030001, China

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062

    Milan, Milano, 20133, Italy

  • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 266859

    Rome, Roma, 00168, Italy

  • Fujitsu Clinic /ID# 266877

    Kawasaki-shi, Kanagawa, 211-8588, Japan

  • Guy's and St Thomas' NHS Foundation Trust /ID# 267587

    London, Greater London, SE1 9RT, United Kingdom

  • Hallym University Dongtan Sacred Heart Hospital /ID# 267473

    Hwaseong, Gyeonggido, 18450, South Korea

  • Hebei General Hospital /ID# 267663

    Shijiazhuang, Hebei, 500051, China

  • Hospital Clinic de Barcelona /ID# 276468

    Barcelona, 08036, Spain

  • Hospital Clinico San Carlos /ID# 275896

    Madrid, 28040, Spain

  • Hospital Clinico Universitario de Valladolid /ID# 275899

    Valladolid, 47003, Spain

  • Hospital Universitari Vall d Hebron /ID# 276467

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz /ID# 276332

    Madrid, 28046, Spain

  • Hospital da Luz /ID# 266182

    Lisbon, Lisbon District, 1500-650, Portugal

  • ICOT Istituto Marco Pasquali /ID# 267288

    Latina, 04100, Italy

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Istituto Auxologico Italiano - Ospedale San Luca /ID# 276161

    Milan, Milano, 20149, Italy

  • Kangbuk Samsung Hospital /ID# 267475

    Seoul, Seoul Teugbyeolsi, 03181, South Korea

  • Klinikum Ibbenbueren /ID# 267393

    Ibbenbueren, North Rhine-Westphalia, 49477, Germany

  • Konan Medical Center /ID# 266867

    Kobe, Hyōgo, 658-0064, Japan

  • Linkou Chang Gung Memorial Hospital /ID# 266424

    Taoyuan City, 333, Taiwan

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437

    Wroclaw, 52-210, Poland

  • MIND Clinic /ID# 267652

    Budapest, 1024, Hungary

  • Mackay Memorial Hospital /ID# 266421

    Taipei, 104, Taiwan

  • Minksneuro /ID# 267651

    Brno, Brno-mesto, 603 00, Czechia

  • Nagaseki Headache Clinic /ID# 266865

    Kai, Yamanashi, 400-0124, Japan

  • Nanfang Hospital - Southern Medical University /ID# 268510

    Guangzhou, Guangdong, 510000, China

  • National Cheng Kung University Hospital /ID# 267754

    Tainan, 704, Taiwan

  • Neuro Centrum Odenwald - Praxis Erbach /ID# 276171

    Erbach im Odenwald, Hesse, 64711, Germany

  • Neuro plus s.r.o. /ID# 266052

    Olomouc, 775 00, Czechia

  • Neuro-Care Sp. z o.o. sp.k /ID# 267883

    Katowice, Silesian Voivodeship, 40-749, Poland

  • NeuroHK s.r.o. /ID# 266051

    Hradec Králové, 500 09, Czechia

  • Neurologie Brno /ID# 266050

    Brno, 616 00, Czechia

  • Neurozentrum Bielefeld /ID# 276170

    Bielefeld, North Rhine-Westphalia, 33647, Germany

  • Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433

    Katowice, Silesian Voivodeship, 40-584, Poland

  • Nowon Eulji Medical Center, Eulji University /ID# 267474

    Seoul, Seoul Teugbyeolsi, 01830, South Korea

  • Ooba Clinic For Neurosurgery & Headache /ID# 266866

    Ōita, Oita Prefecture, 870-0831, Japan

  • Oxford University Hospitals - John Radcliffe Hospital /ID# 267659

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Penta Hospitals Badania Kliniczne /ID# 266732

    Wroclaw, Lower Silesian Voivodeship, 54-429, Poland

  • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285

    Chemnitz, Saxony, 09111, Germany

  • Pratia Prague /ID# 268252

    Prague, Praha, Hlavni Mesto, 130 00, Czechia

  • Renmin Hospital of Wuhan University /ID# 267671

    Wuhan, Hubei, 430060, China

  • Royal Sussex County Hospital /ID# 268362

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • S-Medicon Kft /ID# 266637

    Budapest, 1138, Hungary

  • SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Semmelweis Egyetem /ID# 266636

    Budapest, 1085, Hungary

  • Semmelweis Egyetem /ID# 266752

    Budapest, 1085, Hungary

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864

    Sendai, Miyagi, 982-0014, Japan

  • Seoul National University Hospital /ID# 267477

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shaanxi Provincial PeopleS Hospital /ID# 267827

    Xi'an, Shaanxi, 710054, China

  • Solumed Centrum Medyczne /ID# 267220

    Poznan, Greater Poland Voivodeship, 60-529, Poland

  • St Pancras Clinical Research - London /ID# 268653

    London, Greater London, EC2Y 8EA, United Kingdom

  • Studienzentrum Nord-West /ID# 267311

    Westerstede, Lower Saxony, 26655, Germany

  • Taipei Veterans General Hospital /ID# 266418

    Taipei, 112, Taiwan

  • The Adam Practice - Upton Cross /ID# 268116

    Poole, Dorset, BH16 5PW, United Kingdom

  • The First Affiliated Hospital of Soochow University /ID# 267885

    Suzhou, Jiangsu, 215006, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Medical University General Hospital /ID# 268846

    Tianjin, Tianjin Municipality, 300052, China

  • Tianjin People's Hospital /ID# 268511

    Tianjin, Tianjin Municipality, 300120, China

  • Tokyo Headache Clinic /ID# 266863

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Tominaga Clinic - Osaka /ID# 268228

    Osaka, Osaka, 556-0015, Japan

  • UNO Medical Trials /ID# 266643

    Budapest, 1135, Hungary

  • Umenotsuji Clinic /ID# 266834

    Kochi, Kochi, 780-8011, Japan

  • Unidade Local de Saude Sao Joao /ID# 266185

    Porto, 4200-319, Portugal

  • Unidade Local de Saude da Arrabida, EPE /ID# 266183

    Setúbal, 2910-446, Portugal

  • Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187

    Aveiro, 3814-501, Portugal

  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 276215

    Almada, Setúbal District, 2805-267, Portugal

  • Unidade Local de Saude de Loures-Odivelas /ID# 266190

    Loures, Lisbon District, 2674-514, Portugal

  • Unidade Local de Saude de Matosinhos EPE /ID# 266170

    Senhora da Hora, Porto District, 4464-513, Portugal

  • Unidade Local de Saude de Santa Maria /ID# 275932

    Lisbon, 1649-035, Portugal

  • Unidade Local de Saude do Alto Ave, EPE /ID# 266168

    Guimarães, Braga District, 4835-044, Portugal

  • Universitaetsmedizin Greifswald /ID# 267277

    Greifswald, Mecklenburg-Vorpommern, 17489, Germany

  • Usuda Clinic Of Internal Medicine /ID# 266870

    Setagaya-ku, Tokyo, 156-0043, Japan

  • Uzsoki Utcai Korhaz /ID# 266641

    Budapest, 1145, Hungary

  • Vseobecna Fakultni nemocnice v Praze /ID# 268100

    Prague, Praha 17, 128 00, Czechia

  • Yonsei University Health System Severance Hospital /ID# 267476

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • Zentrum Fuer Neurologisch-Psychiatrische Studien Siegen /ID# 268247

    Siegen, North Rhine-Westphalia, 57076, Germany