Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine

Migraine Clinical Trial

— ECLIPSE  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241313
• Other study ID #: M24-305
• Secondary ID: 2023-506029-12-0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 25, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: November 30, 2025
• Est. primary completion date: October 5, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Atogepant
Oral Tablet
• Placebo for Atogepant
Oral Tablet

Locations

Country	Name	City	State
Belgium	H.-Hartziekenhuis Lier /ID# 257577	Lier
Belgium	Cabinet Prive Dr Sava /ID# 257581	Saint-Nicolas
China	Beijing Friendship Hospital /ID# 258830	Beijing	Beijing
China	Chinese PLA General Hospital /ID# 257540	Beijing	Beijing
China	The Second hospital of Jilin university /ID# 258556	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University /ID# 258787	Changsha	Hunan
China	The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University /ID# 259536	Guiyang	Guizhou
China	Hainan General Hospital /ID# 259548	Haikou	Hainan
China	The Second Affiliated Hospital of Nanjing Medical University /ID# 258648	Nanjing	Jiangsu
China	Jiangxi Pingxiang People's Hospital /ID# 258652	Pingxiang	Jiangxi
China	The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554	Shanghai
China	The University of Hong Kong- Shenzhen Hospital /ID# 258462	Shenzhen	Guangdong
China	The First Affiliated Hospital of Soochow University /ID# 258783	Suzhou	Jiangsu
China	Tianjin Medical University General Hospital /ID# 259513	Tianjin
China	Tianjin People's Hospital /ID# 258625	Tianjin
Czechia	CCR Ostrava, s.r.o. /ID# 257743	Ostrava
Czechia	FORBELI s.r.o. /ID# 259019	Prague
Czechia	Clintrial s.r.o. /ID# 257663	Prague 10
Czechia	DADO MEDICAL s.r.o. /ID# 257672	Praha
Czechia	Fakultni Thomayerova nemocnice /ID# 259021	Praha
Czechia	INEP medical s.r.o. /ID# 257669	Praha
Czechia	Praglandia s.r.o. /ID# 257667	Praha 5
Germany	Kopfschmerzzentrum Frankfurt /ID# 258019	Frankfurt am Main
Germany	AmBeNet GmbH /ID# 258075	Leipzig
Germany	Studienzentrum Nord-West /ID# 258024	Westerstede
Italy	ICOT Istituto Marco Pasquali /ID# 258621	Latina
Italy	Istituto Auxologico Italiano /ID# 258623	Milan
Italy	Istituto Neurologico Mediterraneo Neuromed /ID# 258593	Pozzilli
Japan	DOI Internal Medicine-Neurology Clinic /ID# 259009	Hiroshima
Japan	Tokyo Dental College Ichikawa General Hospital /ID# 259570	Ichikawa-shi	Chiba
Japan	Nagaseki Headache Clinic /ID# 259214	Kai-shi	Yamanashi
Japan	Ikeda Neurosurgical Clinic /ID# 259085	Kasuga-shi	Fukuoka
Japan	Umenotsuji Clinic /ID# 258717	Kochi-shi	Kochi
Japan	Tatsuoka Neurology Clinic /ID# 258771	Kyoto
Japan	Tominaga Clinic /ID# 258553	Osaka-shi	Osaka
Japan	Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 262708	Sapporo-shi	Hokkaido
Japan	Sendai Headache and Neurology Clinic Medical Corporation /ID# 258862	Sendai-shi	Miyagi
Japan	Usuda Clinic Of Internal Medicine /ID# 260422	Setagaya-ku	Tokyo
Japan	Tokyo Headache Clinic /ID# 258534	Shibuya-ku	Tokyo
Korea, Republic of	Chonnam National University Hospital /ID# 259154	??	Jeonranamdo
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital /ID# 257999	Hwaseong	Gyeonggido
Korea, Republic of	Kangbuk Samsung Hospital /ID# 258001	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Nowon Eulji Medical Center, Eulji University /ID# 258000	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 258002	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 257998	Seoul	Seoul Teugbyeolsi
Poland	Athleticomed Sp. z o.o /ID# 258253	Bydgoszcz	Kujawsko-pomorskie
Poland	Vitamed Galaj i Cichomski Sp.j. /ID# 258278	Bydgoszcz	Kujawsko-pomorskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 258250	Gdansk	Pomorskie
Poland	Silmedic Sp. z o.o. /ID# 258249	Katowice	Slaskie
Poland	Linden Sp. z o.o. sp.k. /ID# 258283	Krakow	Malopolskie
Poland	Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 258281	Lublin	Lubelskie
Poland	Instytut Zdrowia Dr Boczarska Jedynak /ID# 258248	Oswiecim	Malopolskie
Poland	Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 258268	Poznan	Wielkopolskie
Poland	Solumed Centrum Medyczne /ID# 258288	Poznan	Wielkopolskie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 258287	Wroclaw
Portugal	Unidade Local de Saude de Almada-Seixal, EPE /ID# 257987	Almada
Portugal	Unidade Local de Saude do Alto Ave, EPE /ID# 257986	Guimaraes	Braga
Portugal	Hospital da Luz Lisboa /ID# 257983	Lisboa
Portugal	Unidade Local de Saude de Santa Maria, EPE /ID# 257989	Lisboa
Portugal	Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 258140	Porto
Portugal	Unidade Local de Saude da Arrabida, EPE /ID# 258139	Setubal
Slovakia	MUDr. Beata Dupejova neurologicka ambulancia s.r.o. /ID# 257901	Banska Bystrica
Slovakia	Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 257961	Bratislava
Slovakia	University Hospital Bratislava - Hospital ak. L. Derera /ID# 257947	Bratislava	Bratislavsky Kraj
Slovakia	Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu Liptovsky Mikulas /ID# 258315	Liptovsky Mikulas
Slovakia	Neurologicka a algeziologicka ambulancia, SANERA /ID# 259176	Prešov	Presovsky Kraj
Spain	Hospital Universitario Vall d'Hebron /ID# 257652	Barcelona
Spain	Hospital Universitario La Paz /ID# 257654	Madrid
Spain	Clinica Universidad de Navarra - Pamplona /ID# 257656	Pamplona	Navarra
Spain	Hospital Universitario Marques de Valdecilla /ID# 257658	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocio /ID# 257657	Sevilla
Spain	Hospital Universitario y Politecnico La Fe /ID# 257655	Valencia
Spain	Hospital Clinico Universitario de Valladolid /ID# 257653	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa /ID# 257661	Zaragoza
Sweden	CTC EbbePark Linkoping /ID# 261170	Linköping
Sweden	Neurology Clinic /ID# 258835	Stockholm
Sweden	Optimuskliniken /ID# 258834	Upplands Vasby
Taiwan	China Medical University Hospital /ID# 258417	Taichung
Taiwan	Kuang-Tien General Hospital /ID# 258063	Taichung City
Taiwan	Taipei Veterans General Hospital /ID# 258062	Taipei City	Taipei
Taiwan	Tri-Service General Hospital /ID# 258064	Taipei City
Taiwan	Linkou Chang Gung Memorial Hospital /ID# 259171	Taoyuan City
United Kingdom	Re:Cognition Health Birmingham /ID# 258186	Birmingham
United Kingdom	Re:Cognition Health Bristol /ID# 258187	Bristol	Bristol, City Of
United Kingdom	Royal Primary Care Ashgate /ID# 258923	Derbyshire
United Kingdom	NHS Greater Glasgow and Clyde /ID# 259384	Glasgow	Scotland
United Kingdom	Re:Cognition Health - Guildford /ID# 258188	Guildford
United Kingdom	St Pancras Clinical Research /ID# 258183	London
United Kingdom	North Coast Medical Ltd - Newquay Health Centre /ID# 260019	Newquay	Cornwall
United Kingdom	The University of Nottingham Health Service /ID# 259380	Nottingham
United Kingdom	The Adam Practice /ID# 258190	Poole	Dorset
United Kingdom	Primary Care Sheffield /ID# 259448	Sheffield

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Belgium,  China,  Czechia,  Germany,  Italy,  Japan,  Korea, Republic of,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks
Secondary	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	Percentage of Participants With Absence of Most Bothersome Migraine-associated Symptom (MBS) will be assessed.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Relief at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After DB Dose for the First Attack	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After DB Dose for the First Attack	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants With Use of Rescue Medication Within 24 Hours After DB Dose for the First Attack	Percentage of participants with use of rescue medication within 24 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Secondary	Percentage of Participants With Ability to Function Normally at 2 Hours After DB Dose for the First Attack	Percentage of participants with ability to function normally at 2 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After DB Dose for the First Attack	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After DB Dose for the First Attack	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants With Absence of Photophobia at 2 Hours After the DB Dose for the First Attack	Photophobia is defined as sensitivity to light.	Approximately 16 Weeks
Secondary	Percentage of Participants With Absence of Phonophobia at 2 Hours After the DB Dose for the First Attack	Phonophobia is defined as sensitivity to sound.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Freedom at 8 Hours After the DB Dose for the First Attack	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks
Secondary	Percentage of Participants With Ability to Function Normally at 8 Hours After DB Dose for the First Attack	Percentage of participants with ability to function normally at 8 hours after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Relief at 1 Hour After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Secondary	Percentage of Participants With Absence of Nausea at 2 Hours After the Double-Blind (DB) Dose for the First Attack	Percentage of participants with absence of nausea at 2 hours after the DB dose for the first attack.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Relief at 30 Minutes After the Double-Blind (DB) Dose for the First Attack	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Secondary	Percentage of Participants With Ability to Function Normally at 1 Hour After DB Dose for the First Attack	Percentage of participants with ability to function normally at 1 hour after the DB dose for the first attack will be assessed.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Freedom at 2 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Pain Relief at 2 Hours After Receiving Double-Blind (DB) Atogepant for at least 2 out of 3 Attacks	Pain relief is defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Freedom From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Freedom From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain freedom is defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Relief From 2 to 24 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks
Secondary	Percentage of Participants Achieving Sustained Pain Relief From 2 to 48 Hours After Receiving DB Atogepant for at least 2 out of 3 Attacks	Sustained pain relief is defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours.	Approximately 16 Weeks

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