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Menstrual Migraine (MM)Phase 3ATO MMNCT06806293

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

A Phase 3 study testing Atogepant in people with Menstrual Migraine (MM), run by AbbVie at 95 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Menstrual Migraine (MM)
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
468 participants
Where
95 sitesin 12 countries
Study dates
10 Feb 2025to Jul 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

China10 sites

  • Chinese PLA General Hospital /ID# 267141

    Beijing, Beijing Municipality, 100039

  • Nanfang Hospital - Southern Medical University /ID# 268510

    Guangzhou, Guangdong, 510000

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

    Hangzhou, Zhejiang, 310009

  • Hebei General Hospital /ID# 267663

    Shijiazhuang, Hebei, 500051

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

    Suzhou, Jiangsu, 215006

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

    Taiyuan, Shanxi, 030001

  • Tianjin Medical University General Hospital /ID# 268846

    Tianjin, Tianjin Municipality, 300052

  • Tianjin People's Hospital /ID# 268511

    Tianjin, Tianjin Municipality, 300120

  • Renmin Hospital of Wuhan University /ID# 267671

    Wuhan, Hubei, 430060

  • Shaanxi Provincial PeopleS Hospital /ID# 267827

    Xi'an, Shaanxi, 710054

Other trials in China

Czechia10 sites

  • Minksneuro /ID# 267651

    Brno, Brno-mesto, 603 00

  • Neurologie Brno /ID# 266050

    Brno, 616 00

  • NeuroHK s.r.o. /ID# 266051

    Hradec Králové, 500 09

  • Neuro plus s.r.o. /ID# 266052

    Olomouc, 775 00

  • A-Shine s.r.o. /ID# 266048

    Pilsen, Plzeň Region, 301 00

  • Vseobecna Fakultni nemocnice v Praze /ID# 268100

    Prague, Praha 17, 128 00

  • DADO MEDICAL s.r.o. /ID# 267629

    Prague, Praha 2, 120 00

  • Pratia Prague /ID# 268252

    Prague, Praha, Hlavni Mesto, 130 00

  • Clintrial s.r.o. /ID# 266047

    Prague, 100 00

  • Fakultni Thomayerova nemocnice /ID# 266049

    Prague, 140 59

Other trials in Czechia

Japan10 sites

  • Nagaseki Headache Clinic /ID# 266865

    Kai, Yamanashi, 400-0124

  • Fujitsu Clinic /ID# 266877

    Kawasaki-shi, Kanagawa, 211-8588

  • Konan Medical Center /ID# 266867

    Kobe, Hyōgo, 658-0064

  • Umenotsuji Clinic /ID# 266834

    Kochi, Kochi, 780-8011

  • Ooba Clinic For Neurosurgery & Headache /ID# 266866

    Ōita, Oita Prefecture, 870-0831

  • Chibune General Hospital /ID# 266874

    Osaka, Osaka, 555-0034

  • Tominaga Clinic - Osaka /ID# 268228

    Osaka, Osaka, 556-0015

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

    Sendai, Miyagi, 982-0014

  • Usuda Clinic Of Internal Medicine /ID# 266870

    Setagaya-ku, Tokyo, 156-0043

  • Tokyo Headache Clinic /ID# 266863

    Shibuya-ku, Tokyo, 151-0051

Other trials in Japan

Portugal10 sites

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

    Almada, Setúbal District, 2805-267

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

    Aveiro, 3814-501

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

    Braga, 4710-243

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

    Guimarães, Braga District, 4835-044

  • Hospital da Luz /ID# 266182

    Lisbon, Lisbon District, 1500-650

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

    Lisbon, 1649-035

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

    Loures, Lisbon District, 2674-514

  • Unidade Local de Saude Sao Joao /ID# 266185

    Porto, 4200-319

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

    Senhora da Hora, Porto District, 4464-513

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

    Setúbal, 2910-446

Other trials in Portugal

Germany9 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310

    Berlin, 10117

  • Neurozentrum Bielefeld /ID# 276170

    Bielefeld, North Rhine-Westphalia, 33647

  • Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285

    Chemnitz, Saxony, 09111

  • Neuro Centrum Odenwald - Praxis Erbach /ID# 276171

    Erbach im Odenwald, Hesse, 64711

  • Universitaetsmedizin Greifswald /ID# 267277

    Greifswald, Mecklenburg-Vorpommern, 17489

  • Klinikum Ibbenbueren /ID# 267393

    Ibbenbueren, North Rhine-Westphalia, 49477

  • Ambenet Hausarztpraxis /ID# 267309

    Leipzig, Saxony, 04107

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

    Siegen, North Rhine-Westphalia, 57076

  • Studienzentrum Nord-West /ID# 267311

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Italy9 sites

  • Azienda Ospedaliero Universitaria Careggi /ID# 276163

    Florence, Firenze, 50134

  • ICOT Istituto Marco Pasquali /ID# 267288

    Latina, 04100

  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062

    Milan, Milano, 20133

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

    Milan, Milano, 20149

  • Azienda Ospedaliero Universitaria Luigi Vanvitelli/ID#267023

    Naples, Napoli, 80138

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

    Pavia, 27100

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

    Perugia, 06156

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

    Rome, Roma, 00168

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

    Udine, 33100

Other trials in Italy

Hungary8 sites

  • MIND Clinic /ID# 267652

    Budapest, 1024

  • Cortex Study Center /ID# 266639

    Budapest, 1026

  • Clinexpert Kft /ID# 266644

    Budapest, 1033

  • Semmelweis Egyetem /ID# 266636

    Budapest, 1085

  • Semmelweis Egyetem /ID# 266752

    Budapest, 1085

  • UNO Medical Trials /ID# 266643

    Budapest, 1135

  • S-Medicon Kft /ID# 266637

    Budapest, 1138

  • Uzsoki Utcai Korhaz /ID# 266641

    Budapest, 1145

Other trials in Hungary

Poland8 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752

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

    Katowice, Silesian Voivodeship, 40-584

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

    Katowice, Silesian Voivodeship, 40-749

  • SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443

    Krakow, Lesser Poland Voivodeship, 31-501

  • Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Solumed Centrum Medyczne /ID# 267220

    Poznan, Greater Poland Voivodeship, 60-529

  • Penta Hospitals Badania Kliniczne /ID# 266732

    Wroclaw, Lower Silesian Voivodeship, 54-429

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

    Wroclaw, 52-210

Other trials in Poland

United Kingdom6 sites

  • Royal Sussex County Hospital /ID# 268362

    Brighton, East Sussex, BN2 5BE

  • St Pancras Clinical Research - London /ID# 268653

    London, Greater London, EC2Y 8EA

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

    London, Greater London, SE1 9RT

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

    Oxford, Oxfordshire, OX3 9DU

  • The Adam Practice - Upton Cross /ID# 268116

    Poole, Dorset, BH16 5PW

  • Breckland Alliance /ID# 268772

    Thetford, Norfolk, IP24 1JD

Other trials in United Kingdom

South Korea5 sites

  • Hallym University Dongtan Sacred Heart Hospital /ID# 267473

    Hwaseong, Gyeonggido, 18450

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

    Seoul, Seoul Teugbyeolsi, 01830

  • Seoul National University Hospital /ID# 267477

    Seoul, Seoul Teugbyeolsi, 03080

  • Kangbuk Samsung Hospital /ID# 267475

    Seoul, Seoul Teugbyeolsi, 03181

  • Yonsei University Health System Severance Hospital /ID# 267476

    Seoul, Seoul Teugbyeolsi, 03722

Other trials in South Korea

Spain5 sites

  • Hospital Universitari Vall d Hebron /ID# 276467

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 276468

    Barcelona, 08036

  • Hospital Clinico San Carlos /ID# 275896

    Madrid, 28040

  • Hospital Universitario La Paz /ID# 276332

    Madrid, 28046

  • Hospital Clinico Universitario de Valladolid /ID# 275899

    Valladolid, 47003

Other trials in Spain

Taiwan5 sites

  • China Medical University Hospital /ID# 266423

    Taichung, 40447

  • National Cheng Kung University Hospital /ID# 267754

    Tainan, 704

  • Mackay Memorial Hospital /ID# 266421

    Taipei, 104

  • Taipei Veterans General Hospital /ID# 266418

    Taipei, 112

  • Linkou Chang Gung Memorial Hospital /ID# 266424

    Taoyuan City, 333

Other trials in Taiwan

About this study

Official title: 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. 468 adult female participants with menstrual migraine are enrolled in approximately 92 sites across the world.

Read more

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.

Being tested
Atogepant, Placebo for Atogepant
Keywords
Menstrual Migraine, Atogepant, QULIPTA, AQUIPTA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtogepantDrug

    Also called Qulipta, Aquipta

    Oral Tablet

  • Placebo for AtogepantDrug

    Oral Tablet

Study groups in NCT06806293
Study groupRoleWhat they receive
AtogepantExperimentalParticipant will receive atogepant during Double-Blind period and Open-Label period.
Receives: Drug: Atogepant
Placebo for AtogepantPlacebo comparatorParticipant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
Receives: Drug: Atogepant; Drug: Placebo for Atogepant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Measured: Up to approximately 120 days

Secondary outcomes (8)

  1. Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Measured: Up to approximately 120 days

  2. Change in Number of Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

    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.

    Measured: Up to approximately 120 days

  3. Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Measured: Up to approximately 120 days

  4. Change in Number of Acute Medication Use Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

    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.

    Measured: Up to approximately 120 days

  5. Change in Number of Moderate or Severe Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period

    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.

    Measured: Up to approximately 120 days

  6. Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period

    A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Measured: Up to approximately 120 days

  7. Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS) Across 3 Menstrual Cycles During the Double-Blind Period

    FDS is a single item used to measure the participant's level of functional disability.

    Measured: Up to approximately 120 days

  8. Percentage of Participants With No Difficult At All/Little Difficult in Thinking Clearly for 100% of PMP Days As Assessed by Cognitive Function Scale (CFS) Across 3 Menstrual Cycles During the Double-Blind Period

    Cognitive Function Scale is a single item used to measure the subject's difficulty in thinking clearly.

    Measured: Up to approximately 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start10 Feb 2025
  3. Primary completion29 Jun 2026
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06806293
Sponsor's protocol ID
M24-859
Other IDs
2024-512946-41-00
Acronym
ATO MM
Status last verified
Sep 2026
First submitted
29 Jan 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant in people with Menstrual Migraine (MM), run by AbbVie at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in China, Czechia, Japan, Portugal, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period (time frame: Up to approximately 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06806293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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