Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine (ATO MM)

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM.

Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. Approximately 430 adult female participants with menstrual migraine will be enrolled in approximately 85 sites across the world.

Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Study Overview

• Status: Active, not recruiting
• Conditions: Menstrual Migraine (MM)
• Intervention / Treatment: Drug: Atogepant; Drug: Placebo for Atogepant

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100039
      • Chinese PLA General Hospital /ID# 267141
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Nanfang Hospital - Southern Medical University /ID# 268510
  • Hebei
    • Shijiazhuang, Hebei, China, 500051
      • Hebei General Hospital /ID# 267663
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University /ID# 267671
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University /ID# 267885
  • Shaanxi
    • Xi'an, Shaanxi, China, 710054
      • Shaanxi Provincial PeopleS Hospital /ID# 267827
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • First Affiliated Hospital of Shanxi Medical University /ID# 267680
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital /ID# 268846
    • Tianjin, Tianjin Municipality, China, 300120
      • Tianjin People's Hospital /ID# 268511
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
• Czechia
  • Brno, Czechia, 616 00
    • Neurologie Brno /ID# 266050
  • Hradec Králové, Czechia, 500 09
    • NeuroHK s.r.o. /ID# 266051
  • Olomouc, Czechia, 775 00
    • Neuro plus s.r.o. /ID# 266052
  • Prague, Czechia, 100 00
    • Clintrial s.r.o. /ID# 266047
  • Prague, Czechia, 130 00
    • Pratia Prague s.r.o. /ID# 268252
  • Prague, Czechia, 140 59
    • Fakultni Thomayerova nemocnice /ID# 266049
  • Brno-mesto
    • Brno, Brno-mesto, Czechia, 603 00
      • Minksneuro /ID# 267651
  • Plzeň Region
    • Pilsen, Plzeň Region, Czechia, 301 00
      • A-Shine s.r.o. /ID# 266048
  • Praha 17
    • Prague, Praha 17, Czechia, 128 00
      • Vseobecna Fakultni nemocnice v Praze /ID# 268100
  • Praha 2
    • Prague, Praha 2, Czechia, 120 00
      • DADO MEDICAL s.r.o. /ID# 267629
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310
  • Hesse
    • Erbach im Odenwald, Hesse, Germany, 64711
      • Neuro Centrum Odenwald - Praxis Erbach /ID# 276171
  • Lower Saxony
    • Westerstede, Lower Saxony, Germany, 26655
      • Studienzentrum Nord-West /ID# 267311
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17489
      • Universitaetsmedizin Greifswald /ID# 267277
  • North Rhine-Westphalia
    • Bielefeld, North Rhine-Westphalia, Germany, 33647
      • Neurozentrum Bielefeld /ID# 276170
    • Ibbenbueren, North Rhine-Westphalia, Germany, 49477
      • Klinikum Ibbenbueren /ID# 267393
    • Siegen, North Rhine-Westphalia, Germany, 57076
      • ZNS Siegen /ID# 268247
  • Saxony
    • Chemnitz, Saxony, Germany, 09111
      • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285
    • Leipzig, Saxony, Germany, 04107
      • Ambenet Hausarztpraxis /ID# 267309
• Hungary
  • Budapest, Hungary, 1024
    • MIND Clinic /ID# 267652
  • Budapest, Hungary, 1026
    • Cortex Study Center /ID# 266639
  • Budapest, Hungary, 1033
    • Clinexpert Kft /ID# 266644
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 266636
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem /ID# 266752
  • Budapest, Hungary, 1135
    • UNO Medical Trials /ID# 266643
  • Budapest, Hungary, 1138
    • S-Medicon Kft /ID# 266637
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház /ID# 266641
• Italy
  • Latina, Italy, 04100
    • ICOT Istituto Marco Pasquali /ID# 267288
  • Pavia, Italy, 27100
    • Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926
  • Udine, Italy, 33100
    • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019
  • Firenze
    • Florence, Firenze, Italy, 50134
      • Azienda Ospedaliero Universitaria Careggi /ID# 276163
  • Milano
    • Milan, Milano, Italy, 20133
      • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062
    • Milan, Milano, Italy, 20149
      • Istituto Auxologico Italiano - Ospedale San Luca /ID# 276161
  • Napoli
    • Naples, Napoli, Italy, 80138
      • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 267023
  • Roma
    • Rome, Roma, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 266859
• Japan
  • Hyōgo
    • Kobe, Hyōgo, Japan, 658-0064
      • Konan Medical Center /ID# 266867
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8588
      • Fujitsu Clinic /ID# 266877
  • Kochi
    • Kochi, Kochi, Japan, 780-8011
      • Umenotsuji Clinic /ID# 266834
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0014
      • Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864
  • Oita Prefecture
    • Ōita, Oita Prefecture, Japan, 870-0831
      • Ooba Clinic For Neurosurgery & Headache /ID# 266866
  • Osaka
    • Osaka, Osaka, Japan, 555-0034
      • Chibune General Hospital /ID# 266874
    • Osaka, Osaka, Japan, 556-0015
      • Tominaga Clinic - Osaka /ID# 268228
  • Tokyo
    • Setagaya-ku, Tokyo, Japan, 156-0043
      • Usuda Clinic Of Internal Medicine /ID# 266870
    • Shibuya-ku, Tokyo, Japan, 151-0051
      • Tokyo Headache Clinic /ID# 266863
  • Yamanashi
    • Kai, Yamanashi, Japan, 400-0124
      • Nagaseki Headache Clinic /ID# 266865
• Poland
  • Wroclaw, Poland, 52-210
    • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-529
      • Solumed Centrum Medyczne /ID# 267220
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
      • Athleticomed Sp. z o.o /ID# 266434
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-501
      • SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443
    • Oświęcim, Lesser Poland Voivodeship, Poland, 32-600
      • Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-546
      • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-584
      • Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433
    • Katowice, Silesian Voivodeship, Poland, 40-749
      • Neuro-Care Sp. z o.o. sp.k /ID# 267883
• Portugal
  • Aveiro, Portugal, 3814-501
    • Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187
  • Braga, Portugal, 4710-243
    • 2CA-Braga, Hospital de Braga /ID# 276218
  • Lisbon, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria, EPE /ID# 275932
  • Porto, Portugal, 4200-319
    • Unidade Local de Saude Sao Joao, EPE /ID# 266185
  • Setúbal, Portugal, 2910-446
    • Unidade Local de Saude da Arrabida, EPE /ID# 266183
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Unidade Local de Saude do Alto Ave, EPE /ID# 266168
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1500-650
      • Hospital da Luz /ID# 266182
    • Loures, Lisbon District, Portugal, 2674-514
      • Unidade Local de Saude de Loures-Odivelas, EPE /ID# 266190
  • Porto District
    • Senhora da Hora, Porto District, Portugal, 4464-513
      • Unidade Local de Saude de Matosinhos, EPE /ID# 266170
  • Setúbal District
    • Almada, Setúbal District, Portugal, 2805-267
      • Unidade Local de Saude de Almada-Seixal, EPE /ID# 276215
• South Korea
  • Gyeonggido
    • Hwaseong, Gyeonggido, South Korea, 18450
      • Hallym University Dongtan Sacred Heart Hospital /ID# 267473
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 01830
      • Nowon Eulji Medical Center, Eulji University /ID# 267474
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Seoul National University Hospital /ID# 267477
    • Seoul, Seoul Teugbyeolsi, South Korea, 03181
      • Kangbuk Samsung Hospital /ID# 267475
    • Seoul, Seoul Teugbyeolsi, South Korea, 03722
      • Yonsei University Health System Severance Hospital /ID# 267476
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron /ID# 276467
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 276468
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos /ID# 275896
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 276332
  • Valladolid, Spain, 47003
    • Hospital Clinico Universitario de Valladolid /ID# 275899
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital /ID# 266423
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital /ID# 267754
  • Taipei, Taiwan, 104
    • Mackay Memorial Hospital /ID# 266421
  • Taipei, Taiwan, 112
    • Taipei Veterans General Hospital /ID# 266418
  • Taoyuan City, Taiwan, 333
    • Linkou Chang Gung Memorial Hospital /ID# 266424
• United Kingdom
  • Dorset
    • Poole, Dorset, United Kingdom, BH16 5PW
      • The Adam Practice - Upton Cross /ID# 268116
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Royal Sussex County Hospital /ID# 268362
  • Greater London
    • London, Greater London, United Kingdom, EC2Y 8EA
      • St Pancras Clinical Research /ID# 268653
    • London, Greater London, United Kingdom, SE1 9RT
      • Guy's Hospital /ID# 267587
  • Norfolk
    • Thetford, Norfolk, United Kingdom, IP24 1JD
      • Breckland Alliance /ID# 268772
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Oxford University Hospitals - John Radcliffe Hospital /ID# 267659

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Atogepant; Participant will receive atogepant during Double-Blind period and Open-Label period.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta
Placebo Comparator: Placebo for Atogepant; Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.	Drug: Atogepant; Oral Tablet; Other Names: Qulipta; Aquipta; Drug: Placebo for Atogepant; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to approximately 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to approximately 120 days
Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to approximately 120 days
Change in Number of Acute Medication Use Days During PMP	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.	Up to approximately 120 days
Change in Number of Moderate or Severe Headache Days During PMP	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 120 days
Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs	A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.	Up to approximately 120 days
Change in Number of Headache Days During PMP	A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.	Up to approximately 120 days
Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS)	FDS is a single item used to measure the participant's level of functional disability.	Up to approximately 120 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Menstrual Migraine; Atogepant; QULIPTA; AQUIPTA
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Headache Disorders, Primary; Headache Disorders; Menstruation Disturbances; Migraine Disorders; Premenstrual Syndrome; Substandard Drugs; Pharmaceutical Preparations; atogepant
• Other Study ID Numbers: M24-859; 2024-512946-41 (Other Identifier: EU CT); 2024-512946-41-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about 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

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.: Yes