Clinical trial NCT06241313: Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
Official title: Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Atogepant
ECLIPSE
Qulipta
Aquipta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.

Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.

All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).

There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.


Eligibility criteria: 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.
* History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
* Migraine onset before the age of 50.
* History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

Exclusion Criteria:

* History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
* Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.

Primary outcomes:
measure: Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
Secondary outcomes:
measure: Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) at 2 Hours After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
measure: Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks
timeFrame: Approximately 16 Weeks
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen /ID# 257582
state: Antwerpen
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 257584
state: Bruxelles-Capitale
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis /ID# 257578
state: Limburg
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 257585
city: Kortrijk
country: Belgium
facility: AZ Groeninge /ID# 257586
city: Liege
country: Belgium
facility: CHR de la Citadelle /ID# 257587
city: Lier
country: Belgium
facility: H.-Hartziekenhuis Lier /ID# 257577
city: Saint-Nicolas
country: Belgium
facility: Cabinet Prive Dr Sava /ID# 257581
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college /ID# 258758
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital /ID# 258830
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University /ID# 258510
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 259573
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital /ID# 257540
state: Beijing
city: Xicheng District
country: China
facility: Peking University First Hospital /ID# 258672
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital /ID# 259575
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 259576
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital /ID# 259667
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital /ID# 258656
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638
state: Guangdong
city: Shenzhen
country: China
facility: The University Of Hong Kong - Shenzhen Hospital /ID# 258462
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University /ID# 259536
state: Guizhou
city: Haikou
country: China
facility: Hainan General Hospital /ID# 259548
state: Hainan
city: Shijiazhuang
country: China
facility: Hebei General Hospital /ID# 258583
state: Hebei
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital /ID# 258670
state: Henan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University /ID# 260623
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University /ID# 258787
state: Hunan
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital /ID# 260076
state: Hunan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University /ID# 258648
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University /ID# 259551
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 258783
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital /ID# 258652
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 259585
state: Jilin
city: Changchun
country: China
facility: The Second hospital of Jilin university /ID# 258556
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command /ID# 259556
state: Liaoning
city: XI An
country: China
facility: Shaanxi Provincial People'S Hospital /ID# 259529
state: Shaanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University /ID# 259669
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University /ID# 258664
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 259513
state: Tianjin
city: Tianjin
country: China
facility: Tianjin People's Hospital /ID# 258625
state: Tianjin
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 258860
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 258939
state: Zhejiang
city: Baotou
country: China
facility: Baotou Central Hospital /ID# 258786
city: Shanghai
country: China
facility: The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554
city: Ostrava
country: Czechia
facility: CCR Ostrava, s.r.o. /ID# 257743
state: Ostrava-mesto
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 259023
state: Ostrava-mesto
city: Prague
country: Czechia
facility: Praglandia /ID# 257667
state: Praha 5
city: Hradec Kralove
country: Czechia
facility: NeuroHK s.r.o. /ID# 257671
city: Prague 10
country: Czechia
facility: Clintrial s.r.o. /ID# 257663
city: Prague
country: Czechia
facility: FORBELI s.r.o. /ID# 259019
city: Praha
country: Czechia
facility: DADO MEDICAL s.r.o. /ID# 257672
city: Praha
country: Czechia
facility: Axon Clinical, s.r.o. /ID# 259024
city: Praha
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 259021
city: Praha
country: Czechia
facility: INEP medical s.r.o. /ID# 257669
city: Rychnov nad Kneznou
country: Czechia
facility: Vestra Clinics s.r.o. /ID# 259022
city: Unterhaching
country: Germany
facility: Neuropraxis Muenchen Sued /ID# 258077
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Kopfschmerzzentrum - Frankfurt /ID# 258019
state: Hessen
city: Westerstede
country: Germany
facility: Studienzentrum Nord-West /ID# 258024
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf /ID# 258078
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Ambenet Hausarztpraxis /ID# 258075
state: Sachsen
city: Kiel
country: Germany
facility: Schmerzklinik Kiel /ID# 258005
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076
city: Essen
country: Germany
facility: Universitaetsklinikum Essen /ID# 258023
city: Kassel
country: Germany
facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008
city: Wiesbaden
country: Germany
facility: Velocity Clinical Research /ID# 258020
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház /ID# 258969
state: Pest
city: Budapest
country: Hungary
facility: Cortex Study Center /ID# 259032
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 258546
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 258800
city: Budapest
country: Hungary
facility: UNO Medical Trials /ID# 259186
city: Budapest
country: Hungary
facility: S-Medicon Kft /ID# 258547
city: Pozzilli
country: Italy
facility: Istituto Neurologico Mediterraneo Neuromed /ID# 258593
state: Isernia
city: Avezzano
country: Italy
facility: ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590
state: L Aquila
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele /ID# 258592
state: Milano
city: Milan
country: Italy
facility: Istituto Auxologico Italiano - Irccs /ID# 258623
state: Milano
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591
state: Piemonte
city: Bologna
country: Italy
facility: Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia /ID# 258594
city: Latina
country: Italy
facility: ICOT Istituto Marco Pasquali /ID# 258621
city: Pavia
country: Italy
facility: Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588
city: Savona
country: Italy
facility: Ospedale San Paolo - ASL2 /ID# 258622
city: Ichikawa-shi
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital /ID# 259570
state: Chiba
city: Kasuga-shi
country: Japan
facility: Ikeda Neurosurgical Clinic /ID# 259085
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708
state: Hokkaido
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 258717
state: Kochi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862
state: Miyagi
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 258553
state: Osaka
city: Setagaya-ku
country: Japan
facility: Usuda Clinic Of Internal Medicine /ID# 260422
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Tokyo Headache Clinic /ID# 258534
state: Tokyo
city: Kai
country: Japan
facility: Nagaseki Headache Clinic /ID# 259214
state: Yamanashi
city: Hiroshima
country: Japan
facility: DOI Internal Medicine-Neurology Clinic /ID# 259009
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic /ID# 258771
city: Hwaseong
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital /ID# 257999
state: Gyeonggido
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital /ID# 259154
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University /ID# 258000
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 258002
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 258001
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 257998
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski Sp.j. /ID# 258278
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Athleticomed Sp. z o.o /ID# 258253
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281
state: Lubelskie
city: Krakow
country: Poland
facility: Linden Sp. z o.o. sp.k. /ID# 258283
state: Malopolskie
city: Oświęcim
country: Poland
facility: Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248
state: Malopolskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250
state: Pomorskie
city: Katowice
country: Poland
facility: Silmedic Sp. z o.o. /ID# 258249
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne /ID# 258288
state: Wielkopolskie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 258268
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287
city: Guimaraes
country: Portugal
facility: Unidade Local de Saude do Alto Ave, EPE /ID# 257986
state: Braga
city: Almada
country: Portugal
facility: Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa /ID# 257983
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 257989
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258140
city: Setubal
country: Portugal
facility: Unidade Local de Saude da Arrabida, EPE /ID# 258139
city: Bratislava
country: Slovakia
facility: University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947
state: Bratislavsky Kraj
city: Prešov
country: Slovakia
facility: Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176
state: Presovsky Kraj
city: Liptovsky Mikulas
country: Slovakia
facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315
state: Zilinsky Kraj
city: Banska Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909
city: Bratislava
country: Slovakia
facility: Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 257658
state: Cantabria
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 257656
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 257652
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 257654
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 257657
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 257655
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid /ID# 257653
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 257661
city: Lund
country: Sweden
facility: Skaneuro Privatmottagning /ID# 258833
state: Skane Lan
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset - Huddinge /ID# 258837
state: Stockholms Lan
city: Stockholm
country: Sweden
facility: Neurology Clinic /ID# 258835
state: Stockholms Lan
city: Linköping
country: Sweden
facility: CTC EbbePark Linkoping /ID# 261170
city: Upplands Vasby
country: Sweden
facility: Optimuskliniken /ID# 258834
city: Taichung City
country: Taiwan
facility: Kuang-Tien General Hospital /ID# 258063
state: Taichung
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital /ID# 258062
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 258417
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital /ID# 258064
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 259171
city: Newquay
country: United Kingdom
facility: North Coast Medical Ltd - Newquay Health Centre /ID# 260019
state: Cornwall
city: Poole
country: United Kingdom
facility: The Adam Practice /ID# 258190
state: Dorset
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital /ID# 259384
state: Lanarkshire
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health Birmingham /ID# 258186
city: Bristol
country: United Kingdom
facility: Re:Cognition Health Bristol /ID# 258187
city: Derbyshire
country: United Kingdom
facility: Royal Primary Care Ashgate /ID# 258923
city: Guildford
country: United Kingdom
facility: Re:Cognition Health - Guildford /ID# 258188
city: London
country: United Kingdom
facility: St Pancras Clinical Research /ID# 258183
city: Nottingham
country: United Kingdom
facility: The University of Nottingham Health Service /ID# 259380
city: Sheffield
country: United Kingdom
facility: Primary Care Sheffield /ID# 259448
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: