Phase
Condition
Premenstrual Syndrome
Oral Facial Pain
Migraine (Adult)
Treatment
Placebo for Atogepant
Atogepant
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
History and eDiary confirmation have regular menstrual cycles within the range of 21to 35 days in length (Note: menstrual cycle length is calculated as onset of mensesuntil the day before the next onset of menses).
History of migraine (with or without aura) according to the InternationalClassification of Headache Disorders, 3rd Edition (ICHD-3) for >= 12 months prior toVisit 1/Screening.
Migraine onset before age 50 years.
By history at Visit 1/Screening, participant meets ICHD-3 criteria for puremenstrual migraine with or without aura, or menstrually-related migraine with orwithout aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacksstarting during the PMP (Day -2 to Day +3 relative to menses onset) in the opinionof the investigator.
Participant records 3 perimenstrual periods (PMP) in the eDiary during the screeningperiod, and in at least 2 of 3 PMPs the participant experiences and records amigraine attack in the eDiary with at least 1 migraine day.
Exclusion
Exclusion Criteria:
History of an average of 15 or more headache days per month during the 3 monthsprior to Visit 1/Screening per the investigator's judgment, or a current diagnosisof chronic migraine as defined by International Classification of HeadacheDisorders, 3rd Edition (ICHD-3).
An average of 15 or more headache days per month recorded in the eDiary during thescreening period.
History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine asdefined 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 timeswithin 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 perinvestigator judgment.
Has a condition or situation, which the investigator feels will compromise thesafety of the participant or the quality of the data and renders the subject anunsuitable candidate for the study.
Study Design
Connect with a study center
Chinese PLA General Hospital /ID# 267141
Beijing, Beijing 100039
ChinaActive - Recruiting
Hebei General Hospital /ID# 267663
Shijiazhuang, Hebei 500051
ChinaActive - Recruiting
Pratia Prague s.r.o. /ID# 268252
Prague, 130 00
CzechiaActive - Recruiting
ZNS Siegen /ID# 268247
Siegen, Nordrhein-Westfalen 57076
GermanyActive - Recruiting
Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285
Chemnitz, Sachsen 09111
GermanyActive - Recruiting
Ambenet Hausarztpraxis /ID# 267309
Leipzig, Sachsen 04107
GermanyActive - Recruiting
S-Medicon Kft /ID# 266637
Budapest, 1138
HungaryActive - Recruiting
ICOT Istituto Marco Pasquali /ID# 267288
Latina, 04100
ItalyActive - Recruiting
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922
Pavia, 27100
ItalyActive - Recruiting
Konan Medical Center /ID# 266867
Kobe-shi, Hyogo 658-0064
JapanActive - Recruiting
Fujitsu Clinic /ID# 266877
Kawasaki-shi, Kanagawa 211-8588
JapanActive - Recruiting
Umenotsuji Clinic /ID# 266834
Kochi-shi, Kochi 780-8011
JapanActive - Recruiting
Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864
Sendai-shi, Miyagi 982-0014
JapanActive - Recruiting
Ooba Clinic for Neurosurgery & Headache /ID# 266866
Oita-shi, Oita 870-0831
JapanActive - Recruiting
Chibune General Hospital /ID# 266874
Osaka-shi, Osaka 555-0034
JapanActive - Recruiting
Tominaga Clinic /ID# 268228
Osaka-shi, Osaka 556-0015
JapanActive - Recruiting
Usuda Clinic Of Internal Medicine /ID# 266870
Setagaya-ku, Tokyo 156-0043
JapanActive - Recruiting
Tokyo Headache Clinic /ID# 266863
Shibuya-ku, Tokyo 151-0051
JapanActive - Recruiting
Nagaseki Headache Clinic /ID# 266865
Kai, Yamanashi 400-0124
JapanActive - Recruiting
Athleticomed Sp. z o.o /ID# 266434
Bydgoszcz, Kujawsko-pomorskie 85-752
PolandActive - Recruiting
Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073
Oświęcim, Malopolskie 32-600
PolandActive - Recruiting
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732
Gdansk, Pomorskie 80-546
PolandActive - Recruiting
Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433
Katowice, Slaskie 40-584
PolandActive - Recruiting
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437
Wroclaw, 52-210
PolandActive - Recruiting
Unidade Local de Saude do Alto Ave, EPE /ID# 266168
Guimaraes, Braga 4835-044
PortugalActive - Recruiting
Hospital da Luz /ID# 266182
Lisbon, Lisboa 1500-650
PortugalActive - Recruiting
Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187
Aveiro, 3814-501
PortugalActive - Recruiting
Unidade Local de Saude de Sao Joao, EPE /ID# 266185
Porto, 4202-451
PortugalActive - Recruiting
Unidade Local de Saude de Matosinhos, EPE /ID# 266170
Senhora da Hora, 4464-513
PortugalActive - Recruiting
Unidade Local de Saude da Arrabida, EPE /ID# 266183
Setubal, 2910-446
PortugalActive - Recruiting
China Medical University Hospital /ID# 266423
Taichung, 404
TaiwanActive - Recruiting
National Cheng Kung University Hospital /ID# 267754
Tainan, 704
TaiwanActive - Recruiting
Mackay Memorial Hospital /ID# 266421
Taipei City, 104
TaiwanActive - Recruiting
Taipei Veterans General Hospital /ID# 266418
Taipei City, 112
TaiwanActive - Recruiting
Linkou Chang Gung Memorial Hospital /ID# 266424
Taoyuan City, 333
TaiwanActive - Recruiting
St Pancras Clinical Research /ID# 268653
London, Greater London EC2Y 8EA
United KingdomActive - Recruiting
The Adam Practice /ID# 268116
Poole, BH16 5PW
United KingdomActive - Recruiting
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