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)

Status: Recruiting
Location: See all (138) 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 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
AZ Sint-Jan Brugge /ID# 257585
RECRUITING
Bruges
Universitair Ziekenhuis Antwerpen /ID# 257582
RECRUITING
Edegem
Jessa Ziekenhuis /ID# 257578
RECRUITING
Hasselt
Universitair Ziekenhuis Brussel /ID# 257584
RECRUITING
Jette
AZ Groeninge /ID# 257586
RECRUITING
Kortrijk
CHR de la Citadelle /ID# 257587
RECRUITING
Liège
H.-Hartziekenhuis Lier /ID# 257577
RECRUITING
Lier
Cabinet Prive Dr Sava /ID# 257581
RECRUITING
Saint-nicolas
China
Baotou Central Hospital /ID# 258786
ACTIVE_NOT_RECRUITING
Baotou
Beijing Friendship Hospital /ID# 258830
COMPLETED
Beijing
Chinese PLA General Hospital /ID# 257540
ACTIVE_NOT_RECRUITING
Beijing
Peking University Third Hospital /ID# 259573
ACTIVE_NOT_RECRUITING
Beijing
Xuanwu Hospital Capital Medical University /ID# 258510
ACTIVE_NOT_RECRUITING
Beijing
The first affiliated hospital of bengbu medical college /ID# 258758
ACTIVE_NOT_RECRUITING
Bengbu
The First Hospital of Jilin University /ID# 259585
ACTIVE_NOT_RECRUITING
Changchun
The Second hospital of Jilin university /ID# 258556
COMPLETED
Changchun
The Second Xiangya Hospital Of Central South University /ID# 260623
ACTIVE_NOT_RECRUITING
Changsha
The Third Xiangya Hospital of Central South University /ID# 258787
ACTIVE_NOT_RECRUITING
Changsha
West China Hospital, Sichuan University /ID# 258664
ACTIVE_NOT_RECRUITING
Chengdu
Fujian Medical University Union Hospital /ID# 259575
COMPLETED
Fuzhou
Guangzhou First People's Hospital /ID# 258656
ACTIVE_NOT_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638
ACTIVE_NOT_RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University /ID# 259536
COMPLETED
Guiyang
Hainan General Hospital /ID# 259548
COMPLETED
Haikou
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860
ACTIVE_NOT_RECRUITING
Hangzhou
Lanzhou University Second Hospital /ID# 259667
ACTIVE_NOT_RECRUITING
Lanzhou
The Second Affiliated Hospital of Nanjing Medical University /ID# 258648
ACTIVE_NOT_RECRUITING
Nanjing
Jiangxi Pingxiang Peoples Hospital /ID# 258652
ACTIVE_NOT_RECRUITING
Pingxiang
The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554
COMPLETED
Shanghai
General Hospital of Northern Theater Command /ID# 259556
ACTIVE_NOT_RECRUITING
Shenyang
The University Of Hong Kong - Shenzhen Hospital /ID# 258462
COMPLETED
Shenzhen
Hebei General Hospital /ID# 258583
COMPLETED
Shijiazhuang
The First Affiliated Hospital of Soochow University /ID# 258783
COMPLETED
Suzhou
The Second Affiliated Hospital of Soochow University /ID# 259551
ACTIVE_NOT_RECRUITING
Suzhou
Second Hospital of Shanxi Medical University /ID# 259669
ACTIVE_NOT_RECRUITING
Taiyuan
Tianjin Medical University General Hospital /ID# 259513
RECRUITING
Tianjin
Tianjin People's Hospital /ID# 258625
COMPLETED
Tianjin
The First Affiliated Hospital of Wenzhou Medical University /ID# 258939
COMPLETED
Wenzhou
Shaanxi Provincial PeopleS Hospital /ID# 259529
ACTIVE_NOT_RECRUITING
Xi'an
The First Affiliated Hospital of Xiamen University /ID# 259576
ACTIVE_NOT_RECRUITING
Xiamen
Peking University First Hospital /ID# 258672
ACTIVE_NOT_RECRUITING
Xicheng District
Zhengzhou People's Hospital /ID# 258670
ACTIVE_NOT_RECRUITING
Zhengzhou
Zhuzhou Central Hospital /ID# 260076
ACTIVE_NOT_RECRUITING
Zhuzhou
Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 258076
RECRUITING
Berlin
Universitaetsklinikum Duesseldorf /ID# 258078
RECRUITING
Düsseldorf
Universitaetsklinikum Essen /ID# 258023
RECRUITING
Essen
Kopfschmerzzentrum - Frankfurt /ID# 258019
RECRUITING
Frankfurt Am Main
Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 258008
RECRUITING
Kassel
Schmerzklinik Kiel /ID# 258005
RECRUITING
Kiel
Ambenet Hausarztpraxis /ID# 258075
RECRUITING
Leipzig
Neuropraxis Muenchen Sued /ID# 258077
RECRUITING
Unterhaching
Studienzentrum Nord-West /ID# 258024
RECRUITING
Westerstede
Velocity Clinical Research /ID# 258020
RECRUITING
Wiesbaden
Hungary
Cortex Study Center /ID# 259032
RECRUITING
Budapest
S-Medicon Kft /ID# 258547
RECRUITING
Budapest
Semmelweis Egyetem /ID# 258546
RECRUITING
Budapest
Semmelweis Egyetem /ID# 258800
RECRUITING
Budapest
UNO Medical Trials /ID# 259186
RECRUITING
Budapest
Jávorszky Ödön Kórház /ID# 258969
COMPLETED
Vác
Italy
ASL 1 Abruzzo - Ospedale SS. Filippo and Nicola /ID# 258590
RECRUITING
Avezzano
Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 261089
RECRUITING
Bologna
ASST degli Spedali Civili di Brescia /ID# 258594
RECRUITING
Brescia
ICOT Istituto Marco Pasquali /ID# 258621
RECRUITING
Latina
IRCCS Ospedale San Raffaele /ID# 258592
RECRUITING
Milan
Istituto Auxologico Italiano - Irccs /ID# 258623
RECRUITING
Milan
Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS /ID# 258589
RECRUITING
Pavia
Istituto Neurologico Mediterraneo Neuromed /ID# 258593
RECRUITING
Pozzilli
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 258588
RECRUITING
Roma
Ospedale San Paolo - ASL2 /ID# 258622
RECRUITING
Savona
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 258591
RECRUITING
Turin
Japan
DOI Internal Medicine-Neurology Clinic /ID# 259009
RECRUITING
Hiroshima
Tokyo Dental College Ichikawa General Hospital /ID# 259570
RECRUITING
Ichikawa-shi
Nagaseki Headache Clinic /ID# 259214
RECRUITING
Kai
Ikeda Neurosurgical Clinic /ID# 259085
RECRUITING
Kasuga-shi
Umenotsuji Clinic /ID# 258717
RECRUITING
Kochi
Tatsuoka Neurology Clinic /ID# 258771
RECRUITING
Kyoto
Tominaga Clinic - Osaka /ID# 258553
RECRUITING
Osaka
Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 262708
RECRUITING
Sapporo
Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862
RECRUITING
Sendai
Usuda Clinic Of Internal Medicine /ID# 260422
RECRUITING
Setagaya-ku
Tokyo Headache Clinic /ID# 258534
RECRUITING
Shibuya-ku
Poland
Athleticomed Sp. z o.o /ID# 258253
RECRUITING
Bydgoszcz
Vitamed Galaj i Cichomski Sp.j. /ID# 258278
RECRUITING
Bydgoszcz
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250
RECRUITING
Gdansk
Silmedic Sp. z o.o. /ID# 258249
RECRUITING
Katowice
Linden Sp. z o.o. sp.k. /ID# 258283
RECRUITING
Krakow
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281
RECRUITING
Lublin
Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248
RECRUITING
Oświęcim
Clinical Research Center Medic-R /ID# 258268
RECRUITING
Poznan
Solumed Centrum Medyczne /ID# 258288
RECRUITING
Poznan
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287
RECRUITING
Wroclaw
Portugal
Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987
RECRUITING
Almada
Unidade Local de Saude do Alto Ave, EPE /ID# 257986
RECRUITING
Guimarães
Hospital da Luz Lisboa /ID# 257983
RECRUITING
Lisbon
Unidade Local de Saude de Santa Maria, EPE /ID# 257989
RECRUITING
Lisbon
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258140
RECRUITING
Porto
Unidade Local de Saude da Arrabida, EPE /ID# 258139
RECRUITING
Setúbal
Republic of Korea
Chonnam National University Hospital /ID# 259154
RECRUITING
Gwangju
Hallym University Dongtan Sacred Heart Hospital /ID# 257999
RECRUITING
Hwaseong
Kangbuk Samsung Hospital /ID# 258001
RECRUITING
Seoul
Nowon Eulji Medical Center, Eulji University /ID# 258000
RECRUITING
Seoul
Seoul National University Hospital /ID# 258002
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 257998
RECRUITING
Seoul
Slovakia
MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901
RECRUITING
Banská Bystrica
Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961
RECRUITING
Bratislava
University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947
RECRUITING
Bratislava
Univerzitna nemocnica - Nemocnica svateho Michala a.s. /ID# 257909
RECRUITING
Bratislava
Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315
RECRUITING
Liptovský Mikuláš
Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176
RECRUITING
Prešov
Spain
Hospital Universitario Vall de Hebron /ID# 257652
RECRUITING
Barcelona
Hospital Universitario La Paz /ID# 257654
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona /ID# 257656
RECRUITING
Pamplona
Hospital Universitario Marques de Valdecilla /ID# 257658
RECRUITING
Santander
Hospital Universitario Virgen del Rocio /ID# 257657
RECRUITING
Seville
Hospital Universitario y Politecnico La Fe /ID# 257655
RECRUITING
Valencia
Hospital Clinico Universitario de Valladolid /ID# 257653
RECRUITING
Valladolid
Hospital Clinico Universitario Lozano Blesa /ID# 257661
RECRUITING
Zaragoza
Sweden
Karolinska Universitetssjukhuset - Huddinge /ID# 258837
RECRUITING
Huddinge
CTC EbbePark Linkoping /ID# 261170
RECRUITING
Linköping
Skaneuro Privatmottagning /ID# 258833
RECRUITING
Lund
Neurology Clinic /ID# 258835
RECRUITING
Stockholm
Optimuskliniken /ID# 258834
RECRUITING
Upplands Vasby
Taiwan
China Medical University Hospital /ID# 258417
RECRUITING
Taichung
Kuang-Tien General Hospital /ID# 258063
RECRUITING
Taichung
Tri-Service General Hospital /ID# 258064
RECRUITING
Taipei
Taipei Veterans General Hospital /ID# 258062
RECRUITING
Taipei City
Linkou Chang Gung Memorial Hospital /ID# 259171
RECRUITING
Taoyuan
United Kingdom
Re:Cognition Health Birmingham /ID# 258186
RECRUITING
Birmingham
Re:Cognition Health Bristol /ID# 258187
RECRUITING
Bristol
St Pancras Clinical Research /ID# 277704
RECRUITING
Chester
Ashgate Medical Practice /ID# 258923
RECRUITING
Chesterfield
Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde /ID# 259384
RECRUITING
Glasgow
Re:Cognition Health - Guildford /ID# 258188
RECRUITING
Guildford
St Pancras Clinical Research /ID# 258183
RECRUITING
London
North Coast Medical Ltd - Newquay Health Centre /ID# 260019
RECRUITING
Newquay
The University of Nottingham Health Service /ID# 259380
RECRUITING
Nottingham
The Adam Practice /ID# 258190
RECRUITING
Poole
Primary Care Sheffield /ID# 259448
ACTIVE_NOT_RECRUITING
Sheffield
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2026-11
Participants
Target number of participants: 1300
Treatments
Placebo_comparator: Sequence 1
Participants will receive both atogepant and placebo to treat qualifying migraines.
Experimental: Sequence 2
Participants will receive both atogepant and placebo to treat qualifying migraines.
Experimental: Sequence 3
Participants will receive both atogepant and placebo to treat qualifying migraines.
Experimental: Sequence 4
Participants will receive both atogepant and placebo to treat qualifying migraines.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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