Clinical trial NCT06806293: Study of Oral Atogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Menstrual Migraine (MM)
Keywords: Menstrual Migraine
Atogepant
QULIPTA
AQUIPTA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-02-04
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Primary outcomes:
measure: Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)
timeFrame: Up to approximately 120 days
Secondary outcomes:
measure: Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP
timeFrame: Up to approximately 120 days
measure: Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs
timeFrame: Up to approximately 120 days
measure: Change in Number of Acute Medication Use Days During PMP
timeFrame: Up to approximately 120 days
measure: Change in Number of Moderate or Severe Headache Days During PMP
timeFrame: Up to approximately 120 days
measure: Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs
timeFrame: Up to approximately 120 days
measure: Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS)
timeFrame: Up to approximately 120 days
measure: Change in Number of Headache Days During PMP
timeFrame: Up to approximately 120 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 267141
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital - Southern Medical University /ID# 268510
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital /ID# 267663
state: Hebei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 267885
state: Jiangsu
city: XI An
country: China
facility: Shaanxi Provincial People'S Hospital /ID# 267827
state: Shaanxi
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University /ID# 267680
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 268846
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital /ID# 268511
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 267994
state: Zhejiang
city: Plzen
country: Czechia
facility: A-Shine s.r.o. /ID# 266048
state: Plzensky Kraj
city: Prague
country: Czechia
facility: Všeobecná Fakultní Nemocnice v Praze /ID# 268100
state: Praha 17
city: Brno
country: Czechia
facility: MINKSneuro s.r.o /ID# 267651
city: Brno
country: Czechia
facility: Neurologie Brno /ID# 266050
city: Hradec Kralove
country: Czechia
facility: NeuroHK s.r.o. /ID# 266051
city: Olomouc
country: Czechia
facility: Neuro plus s.r.o. /ID# 266052
city: Prague 10
country: Czechia
facility: Clintrial s.r.o. /ID# 266047
city: Prague
country: Czechia
facility: DADO MEDICAL s.r.o. /ID# 267629
city: Prague
country: Czechia
facility: Pratia Prague s.r.o. /ID# 268252
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 266049
city: Greifswald
country: Germany
facility: Universitaetsmedizin Greifswald /ID# 267277
state: Mecklenburg-Vorpommern
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 267311
state: Niedersachsen
city: Ibbenbüren
country: Germany
facility: Klinikum Ibbenbueren /ID# 267393
state: Nordrhein-Westfalen
city: Siegen
country: Germany
facility: ZNS Siegen /ID# 268247
state: Nordrhein-Westfalen
city: Chemnitz
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 267285
state: Sachsen
city: Leipzig
country: Germany
facility: Ambenet Hausarztpraxis /ID# 267309
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 267310
city: Budapest
country: Hungary
facility: MIND Clinic /ID# 267652
city: Budapest
country: Hungary
facility: Cortex Study Center /ID# 266639
city: Budapest
country: Hungary
facility: Clinexpert Kft /ID# 266644
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 266636
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 266752
city: Budapest
country: Hungary
facility: UNO Medical Trials /ID# 266643
city: Budapest
country: Hungary
facility: S-Medicon Kft /ID# 266637
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház /ID# 266641
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 267062
state: Milano
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 267023
state: Napoli
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 266859
state: Roma
city: Latina
country: Italy
facility: ICOT Istituto Marco Pasquali /ID# 267288
city: Pavia
country: Italy
facility: Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 267922
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 267926
city: Udine
country: Italy
facility: ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 267019
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 266867
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Fujitsu Clinic /ID# 266877
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 266834
state: Kochi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 266864
state: Miyagi
city: Oita-shi
country: Japan
facility: Ooba Clinic for Neurosurgery & Headache /ID# 266866
state: Oita
city: Osaka-shi
country: Japan
facility: Chibune General Hospital /ID# 266874
state: Osaka
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 268228
state: Osaka
city: Setagaya-ku
country: Japan
facility: Usuda Clinic Of Internal Medicine /ID# 266870
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic /ID# 266863
state: Tokyo
city: Kai
country: Japan
facility: Nagaseki Headache Clinic /ID# 266865
state: Yamanashi
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital /ID# 267473
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University /ID# 267474
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 267477
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 267475
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 267476
state: Seoul Teugbyeolsi
city: Bydgoszcz
country: Poland
facility: Athleticomed Sp. z o.o /ID# 266434
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie /ID# 266443
state: Malopolskie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Dr Boczarska Jedynak /ID# 266073
state: Malopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 266732
state: Pomorskie
city: Katowice
country: Poland
facility: Novo-Med Zielinski i wspolnicy SP. J. /ID# 266433
state: Slaskie
city: Katowice
country: Poland
facility: Neuro-Care Sp. z o.o. sp.k /ID# 267883
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 267220
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 266437
city: Guimaraes
country: Portugal
facility: Unidade Local de Saude do Alto Ave, EPE /ID# 266168
state: Braga
city: Lisbon
country: Portugal
facility: Hospital da Luz /ID# 266182
state: Lisboa
city: Senhora da Hora
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE /ID# 266170
state: Porto
city: Aveiro
country: Portugal
facility: Unidade Local de Saude da Regiao de Aveiro, EPE /ID# 266187
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE /ID# 266185
city: Setubal
country: Portugal
facility: Unidade Local de Saude da Arrabida, EPE /ID# 266183
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 266423
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 267754
city: Taipei City
country: Taiwan
facility: Mackay Memorial Hospital /ID# 266421
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 266418
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 266424
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital /ID# 268362
state: East Sussex
city: London
country: United Kingdom
facility: St Pancras Clinical Research /ID# 268653
state: Greater London
city: Poole
country: United Kingdom
facility: The Adam Practice /ID# 268116
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: