Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
NCT ID: NCT06806293
Last Updated: 2025-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
430 participants
INTERVENTIONAL
2025-02-10
2027-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Atogepant
Participant will receive atogepant during Double-Blind period and Open-Label period.
Atogepant
Oral Tablet
Placebo for Atogepant
Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
Atogepant
Oral Tablet
Placebo for Atogepant
Oral Tablet
Interventions
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Atogepant
Oral Tablet
Placebo for Atogepant
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Chinese PLA General Hospital /ID# 267141
Beijing, Beijing Municipality, China
Nanfang Hospital - Southern Medical University /ID# 268510
Guangzhou, Guangdong, China
Hebei General Hospital /ID# 267663
Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University /ID# 267671
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University /ID# 267885
Suzhou, Jiangsu, China
Shaanxi Provincial PeopleS Hospital /ID# 267827
Xi'an, Shaanxi, China
First Affiliated Hospital of Shanxi Medical University /ID# 267680
Taiyuan, Shanxi, China
Tianjin Medical University General Hospital /ID# 268846
Tianjin, Tianjin Municipality, China
Tianjin People's Hospital /ID# 268511
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
Hangzhou, Zhejiang, China
A-Shine s.r.o. /ID# 266048
Pilsen, Plzeň Region, Czechia
Všeobecná Fakultní Nemocnice v Praze /ID# 268100
Prague, Praha 17, Czechia
DADO MEDICAL s.r.o. /ID# 267629
Prague, Praha 2, Czechia
MINKSneuro s.r.o /ID# 267651
Brno, , Czechia
Neurologie Brno /ID# 266050
Brno, , Czechia
NeuroHK s.r.o. /ID# 266051
Hradec Králové, , Czechia
Neuro plus s.r.o. /ID# 266052
Olomouc, , Czechia
Clintrial s.r.o. /ID# 266047
Prague, , Czechia
Pratia Prague s.r.o. /ID# 268252
Prague, , Czechia
Fakultni Thomayerova nemocnice /ID# 266049
Prague, , Czechia
Neuro Centrum Odenwald - Praxis Erbach /ID# 276171
Erbach im Odenwald, Hesse, Germany
Studienzentrum Nord-West /ID# 267311
Westerstede, Lower Saxony, Germany
Universitaetsmedizin Greifswald /ID# 267277
Greifswald, Mecklenburg-Vorpommern, Germany
Neurozentrum Bielefeld /ID# 276170
Bielefeld, North Rhine-Westphalia, Germany
Klinikum Ibbenbueren /ID# 267393
Ibbenbueren, North Rhine-Westphalia, Germany
ZNS Siegen /ID# 268247
Siegen, North Rhine-Westphalia, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285
Chemnitz, Saxony, Germany
Ambenet Hausarztpraxis /ID# 267309
Leipzig, Saxony, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310
Berlin, , Germany
MIND Clinic /ID# 267652
Budapest, , Hungary
Cortex Study Center /ID# 266639
Budapest, , Hungary
Clinexpert Kft /ID# 266644
Budapest, , Hungary
Semmelweis Egyetem /ID# 266636
Budapest, , Hungary
Semmelweis Egyetem /ID# 266752
Budapest, , Hungary
UNO Medical Trials /ID# 266643
Budapest, , Hungary
S-Medicon Kft /ID# 266637
Budapest, , Hungary
Uzsoki Utcai Kórház /ID# 266641
Budapest, , Hungary
Azienda Ospedaliero Universitaria Careggi /ID# 276163
Florence, Firenze, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062
Milan, Milano, Italy
Istituto Auxologico Italiano - Ospedale San Luca /ID# 276161
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 267023
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 266859
Rome, Roma, Italy
ICOT Istituto Marco Pasquali /ID# 267288
Latina, , Italy
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922
Pavia, , Italy
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926
Perugia, , Italy
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019
Udine, , Italy
Konan Medical Center /ID# 266867
Kobe, Hyōgo, Japan
Fujitsu Clinic /ID# 266877
Kawasaki-shi, Kanagawa, Japan
Umenotsuji Clinic /ID# 266834
Kochi, Kochi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864
Sendai, Miyagi, Japan
Ooba Clinic For Neurosurgery & Headache /ID# 266866
Ōita, Oita Prefecture, Japan
Chibune General Hospital /ID# 266874
Osaka, Osaka, Japan
Tominaga Clinic - Osaka /ID# 268228
Osaka, Osaka, Japan
Usuda Clinic Of Internal Medicine /ID# 266870
Setagaya-ku, Tokyo, Japan
Tokyo Headache Clinic /ID# 266863
Shibuya-ku, Tokyo, Japan
Nagaseki Headache Clinic /ID# 266865
Kai, Yamanashi, Japan
Solumed Centrum Medyczne /ID# 267220
Poznan, Greater Poland Voivodeship, Poland
Athleticomed Sp. z o.o /ID# 266434
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443
Krakow, Lesser Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073
Oświęcim, Lesser Poland Voivodeship, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732
Gdansk, Pomeranian Voivodeship, Poland
Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433
Katowice, Silesian Voivodeship, Poland
Neuro-Care Sp. z o.o. sp.k /ID# 267883
Katowice, Silesian Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437
Wroclaw, , Poland
Unidade Local de Saude do Alto Ave, EPE /ID# 266168
Guimarães, Braga District, Portugal
Hospital da Luz /ID# 266182
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 266190
Loures, Lisbon District, Portugal
Unidade Local de Saude de Matosinhos, EPE /ID# 266170
Senhora da Hora, Porto District, Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 276215
Almada, Setúbal District, Portugal
Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187
Aveiro, , Portugal
2CA-Braga, Hospital de Braga /ID# 276218
Braga, , Portugal
Unidade Local de Saude de Santa Maria, EPE /ID# 275932
Lisbon, , Portugal
Unidade Local de Saude Sao Joao, EPE /ID# 266185
Porto, , Portugal
Unidade Local de Saude da Arrabida, EPE /ID# 266183
Setúbal, , Portugal
Hallym University Dongtan Sacred Heart Hospital /ID# 267473
Hwaseong, Gyeonggido, South Korea
Nowon Eulji Medical Center, Eulji University /ID# 267474
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 267477
Seoul, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital /ID# 267475
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 267476
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Clinic de Barcelona /ID# 276468
Barcelona, , Spain
Hospital Clinico San Carlos /ID# 275896
Madrid, , Spain
Hospital Universitario La Paz /ID# 276332
Madrid, , Spain
Hospital Clinico Universitario de Valladolid /ID# 275899
Valladolid, , Spain
China Medical University Hospital /ID# 266423
Taichung, , Taiwan
National Cheng Kung University Hospital /ID# 267754
Tainan City, , Taiwan
Mackay Memorial Hospital /ID# 266421
Taipei, , Taiwan
Taipei Veterans General Hospital /ID# 266418
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 266424
Taoyuan, , Taiwan
Royal Sussex County Hospital /ID# 268362
Brighton, East Sussex, United Kingdom
St Pancras Clinical Research /ID# 268653
London, Greater London, United Kingdom
Guy's Hospital /ID# 267587
London, Greater London, United Kingdom
Breckland Alliance /ID# 268772
Thetford, Norfolk, United Kingdom
Oxford University Hospitals - John Radcliffe Hospital /ID# 267659
Oxford, Oxfordshire, United Kingdom
The Adam Practice /ID# 268116
Poole, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
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Other Identifiers
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2024-512946-41
Identifier Type: OTHER
Identifier Source: secondary_id
M24-859
Identifier Type: -
Identifier Source: org_study_id
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