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

Status: Recruiting
Location: See all (84) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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. 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital /ID# 267141
RECRUITING
Beijing
Nanfang Hospital - Southern Medical University /ID# 268510
RECRUITING
Guangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
RECRUITING
Hangzhou
Hebei General Hospital /ID# 267663
RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University /ID# 267885
RECRUITING
Suzhou
First Affiliated Hospital of Shanxi Medical University /ID# 267680
RECRUITING
Taiyuan
Tianjin Medical University General Hospital /ID# 268846
RECRUITING
Tianjin
Tianjin People's Hospital /ID# 268511
RECRUITING
Tianjin
Renmin Hospital of Wuhan University /ID# 267671
RECRUITING
Wuhan
Shaanxi Provincial PeopleS Hospital /ID# 267827
RECRUITING
Xi'an
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310
RECRUITING
Berlin
Neurozentrum Bielefeld /ID# 276170
RECRUITING
Bielefeld
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285
RECRUITING
Chemnitz
Neuro Centrum Odenwald - Praxis Erbach /ID# 276171
RECRUITING
Erbach Im Odenwald
Universitaetsmedizin Greifswald /ID# 267277
RECRUITING
Greifswald
Klinikum Ibbenbueren /ID# 267393
RECRUITING
Ibbenbueren
Ambenet Hausarztpraxis /ID# 267309
RECRUITING
Leipzig
ZNS Siegen /ID# 268247
RECRUITING
Siegen
Studienzentrum Nord-West /ID# 267311
RECRUITING
Westerstede
Hungary
Clinexpert Kft /ID# 266644
RECRUITING
Budapest
Cortex Study Center /ID# 266639
RECRUITING
Budapest
MIND Clinic /ID# 267652
RECRUITING
Budapest
S-Medicon Kft /ID# 266637
RECRUITING
Budapest
Semmelweis Egyetem /ID# 266636
RECRUITING
Budapest
Semmelweis Egyetem /ID# 266752
RECRUITING
Budapest
UNO Medical Trials /ID# 266643
RECRUITING
Budapest
Uzsoki Utcai Kórház /ID# 266641
RECRUITING
Budapest
Italy
Azienda Ospedaliero Universitaria Careggi /ID# 276163
RECRUITING
Florence
ICOT Istituto Marco Pasquali /ID# 267288
RECRUITING
Latina
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062
RECRUITING
Milan
Istituto Auxologico Italiano - Ospedale San Luca /ID# 276161
RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 267023
RECRUITING
Naples
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922
RECRUITING
Pavia
Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926
COMPLETED
Perugia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 266859
RECRUITING
Rome
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019
RECRUITING
Udine
Japan
Nagaseki Headache Clinic /ID# 266865
RECRUITING
Kai
Fujitsu Clinic /ID# 266877
RECRUITING
Kawasaki-shi
Konan Medical Center /ID# 266867
RECRUITING
Kobe
Umenotsuji Clinic /ID# 266834
RECRUITING
Kochi
Ooba Clinic For Neurosurgery & Headache /ID# 266866
RECRUITING
Ōita
Chibune General Hospital /ID# 266874
RECRUITING
Osaka
Tominaga Clinic - Osaka /ID# 268228
RECRUITING
Osaka
Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864
RECRUITING
Sendai
Usuda Clinic Of Internal Medicine /ID# 266870
RECRUITING
Setagaya-ku
Tokyo Headache Clinic /ID# 266863
RECRUITING
Shibuya-ku
Poland
Athleticomed Sp. z o.o /ID# 266434
RECRUITING
Bydgoszcz
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732
RECRUITING
Gdansk
Neuro-Care Sp. z o.o. sp.k /ID# 267883
RECRUITING
Katowice
Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433
RECRUITING
Katowice
SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443
RECRUITING
Krakow
Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073
RECRUITING
Oświęcim
Solumed Centrum Medyczne /ID# 267220
RECRUITING
Poznan
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437
RECRUITING
Wroclaw
Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 276215
RECRUITING
Almada
Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187
RECRUITING
Aveiro
2CA-Braga, Hospital de Braga /ID# 276218
RECRUITING
Braga
Unidade Local de Saude do Alto Ave, EPE /ID# 266168
RECRUITING
Guimarães
Hospital da Luz /ID# 266182
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE /ID# 275932
RECRUITING
Lisbon
Unidade Local de Saude de Loures-Odivelas, EPE /ID# 266190
RECRUITING
Loures
Unidade Local de Saude Sao Joao, EPE /ID# 266185
RECRUITING
Porto
Unidade Local de Saude de Matosinhos, EPE /ID# 266170
RECRUITING
Senhora Da Hora
Unidade Local de Saude da Arrabida, EPE /ID# 266183
RECRUITING
Setúbal
Republic of Korea
Hallym University Dongtan Sacred Heart Hospital /ID# 267473
RECRUITING
Hwaseong
Kangbuk Samsung Hospital /ID# 267475
RECRUITING
Seoul
Nowon Eulji Medical Center, Eulji University /ID# 267474
RECRUITING
Seoul
Seoul National University Hospital /ID# 267477
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 267476
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona /ID# 276468
RECRUITING
Barcelona
Hospital Clinico San Carlos /ID# 275896
RECRUITING
Madrid
Hospital Universitario La Paz /ID# 276332
RECRUITING
Madrid
Hospital Clinico Universitario de Valladolid /ID# 275899
RECRUITING
Valladolid
Taiwan
China Medical University Hospital /ID# 266423
RECRUITING
Taichung
National Cheng Kung University Hospital /ID# 267754
RECRUITING
Tainan City
Mackay Memorial Hospital /ID# 266421
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 266418
RECRUITING
Taipei
Linkou Chang Gung Memorial Hospital /ID# 266424
RECRUITING
Taoyuan
United Kingdom
Royal Sussex County Hospital /ID# 268362
RECRUITING
Brighton
Guy's Hospital /ID# 267587
RECRUITING
London
St Pancras Clinical Research /ID# 268653
RECRUITING
London
Oxford University Hospitals - John Radcliffe Hospital /ID# 267659
RECRUITING
Oxford
The Adam Practice /ID# 268116
RECRUITING
Poole
Breckland Alliance /ID# 268772
RECRUITING
Thetford
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2027-07
Participants
Target number of participants: 430
Treatments
Experimental: Atogepant
Participant will receive atogepant during Double-Blind period and Open-Label period.
Placebo_comparator: Placebo for Atogepant
Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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