Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
Launched by ABBVIE · Jan 28, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called atogepant, which is taken as a tablet, to see how well it works and how safe it is for adults who experience migraine attacks. Migraines are severe headaches that often come with other symptoms like sensitivity to light and sound, and nausea. The trial aims to find out if atogepant can help treat these migraine attacks quickly. It includes 1,300 participants aged 18 to 75 who have a history of migraines, and they will be part of the study for about 24 weeks.
To participate, individuals should have experienced migraines for at least a year and have had 2 to 8 migraine attacks in the last three months. During the trial, participants will receive either atogepant or a placebo (a non-active treatment) in a way that ensures neither they nor the doctors know which treatment they are receiving at first. After treating a few migraine attacks, everyone will receive atogepant for any further attacks. Participants will visit the clinic regularly and complete questionnaires to monitor their progress and any side effects. This study has a higher level of involvement than standard treatments, but it could provide valuable insights into how to better manage migraine attacks.
Gender
ALL
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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Derbyshire, , United Kingdom
London, , United Kingdom
Newquay, Cornwall, United Kingdom
Poole, Dorset, United Kingdom
Saint Nicolas, , Belgium
Beijing, Beijing, China
Guiyang, Guizhou, China
Pingxiang, Jiangxi, China
Shanghai, , China
Tianjin, , China
Prague 10, , Czechia
Westerstede, , Germany
Latina, , Italy
Kasuga Shi, Fukuoka, Japan
Kochi Shi, Kochi, Japan
Sendai Shi, Miyagi, Japan
Osaka Shi, Osaka, Japan
Setagaya Ku, Tokyo, Japan
Shibuya Ku, Tokyo, Japan
Kai Shi, Yamanashi, Japan
Hiroshima, , Japan
Kyoto, , Japan
Hwaseong, Gyeonggido, Korea, Republic Of
동구, Jeonranamdo, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Bydgoszcz, Kujawsko Pomorskie, Poland
Lublin, Lubelskie, Poland
Krakow, Malopolskie, Poland
Oświęcim, Malopolskie, Poland
Poznan, Wielkopolskie, Poland
Poznan, Wielkopolskie, Poland
Bydgoszcz, , Poland
Guimaraes, Braga, Portugal
Almada, , Portugal
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Setubal, , Portugal
Prešov, Presovsky Kraj, Slovakia
Banska Bystrica, , Slovakia
Santander, Cantabria, Spain
Pamplona, Navarra, Spain
Madrid, , Spain
Sevilla, , Spain
Valladolid, , Spain
Zaragoza, , Spain
Stockholm, , Sweden
Upplands Vasby, , Sweden
Taipei City, Taipei, Taiwan
Taichung City, , Taiwan
Taipei City, , Taiwan
Taoyuan City, , Taiwan
Bristol, Bristol, City Of, United Kingdom
Birmingham, , United Kingdom
Guildford, , United Kingdom
Nottingham, , United Kingdom
Guangzhou, Guangdong, China
Tianjin, , China
Leipzig, , Germany
Frankfurt Am Main, , Germany
Barcelona, , Spain
Taichung, , Taiwan
Bydgoszcz, Kujawsko Pomorskie, Poland
Shenzhen, Guangdong, China
Sapporo Shi, Hokkaido, Japan
Katowice, Slaskie, Poland
Glasgow, Scotland, United Kingdom
Ostrava, , Czechia
Praha 5, , Czechia
Wroclaw, , Poland
Changsha, Hunan, China
Changchun, Jilin, China
Praha, , Czechia
Milan, , Italy
Gdansk, Pomorskie, Poland
Sheffield, , United Kingdom
Prague, , Czechia
Praha, , Czechia
Haikou, Hainan, China
Pozzilli, , Italy
Ichikawa Shi, Chiba, Japan
Bydgoszcz, Kujawsko Pomorskie, Poland
Beijing, Beijing, China
Nanjing, Jiangsu, China
Suzhou, Jiangsu, China
Praha, , Czechia
Liptovsky Mikulas, , Slovakia
Lier, , Belgium
Bratislava, Bratislavsky Kraj, Slovakia
Bratislava, , Slovakia
Valencia, , Spain
Linköping, , Sweden
Edegem, Antwerpen, Belgium
Jette, Bruxelles Capitale, Belgium
Brugge, , Belgium
Kortrijk, , Belgium
Bengbu, Anhui, China
Beijing, Beijing, China
Xicheng District, Beijing, China
Lanzhou, Gansu, China
Guangzhou, Guangdong, China
Beijing, Guizhou, China
Tianjin, Guizhou, China
Tianjin, Guizhou, China
Shijiazhuang, Hebei, China
Zhengzhou, Henan, China
Zhuzhou, Hunan, China
Suzhou, Jiangsu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Baotou, , China
Hradec Kralove, , Czechia
Ostrava, , Czechia
Rychnov Nad Kneznou, , Czechia
Praha, , Czechia
Düsseldorf, Nordrhein Westfalen, Germany
Kiel, Saarland, Germany
Leipzig, Saarland, Germany
Unterhaching, Saarland, Germany
Westerstede, Saarland, Germany
Berlin, , Germany
Essen, , Germany
Kassel, , Germany
Wiesbaden, , Germany
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Avezzano, L Aquila, Italy
Pozzilli, L Aquila, Italy
Milan, Milano, Italy
Rome, Roma, Italy
Brescia, , Italy
Pavia, , Italy
Savona, , Italy
Kyoto, Fukui, Japan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Lisboa, Regiao Autonoma Da Madeira, Portugal
Lisboa, Regiao Autonoma Da Madeira, Portugal
Liptovsky Mikulas, Bratislavsky Kraj, Slovakia
Bratislava, , Slovakia
Lund, Sodermanlands Lan, Sweden
Stockholm, Sodermanlands Lan, Sweden
Taichung City, Keelung, Taiwan
Fuzhou, Fujian, China
Wenzhou, Zhejiang, China
Changsha, Guizhou, China
Xi An, Shaanxi, China
Milan, Milano, Italy
Shenyang, Liaoning, China
Xiamen, Fujian, China
Hangzhou, Zhejiang, China
Ostrava, , Czechia
Bologna, , Italy
Pavia, , Italy
Roma, , Italy
Huddinge, Stockholms Lan, Sweden
Hasselt, Limburg, Belgium
Budapest, , Hungary
Brescia, , Italy
Liege, , Belgium
Beijing, Beijing, China
Changsha, Hunan, China
Tianjin, Tianjin, China
Tianjin, Tianjin, China
Ostrava, Ostrava Mesto, Czechia
Ostrava, Ostrava Mesto, Czechia
Hradec Kralove, , Czechia
Rychnov Nad Kneznou, , Czechia
Unterhaching, Bayern, Germany
Westerstede, Niedersachsen, Germany
Leipzig, Sachsen, Germany
Kiel, Schleswig Holstein, Germany
Pozzilli, Isernia, Italy
Liptovsky Mikulas, Zilinsky Kraj, Slovakia
Lund, Skane Lan, Sweden
Stockholm, Stockholms Lan, Sweden
Taichung City, Taichung, Taiwan
Prague, Praha 5, Czechia
Berlin, , Germany
Milan, Milano, Italy
Bristol, , United Kingdom
Torino, Piemonte, Italy
Budapest, , Hungary
Vác, Pest, Hungary
Shenzhen, Guangdong, China
Frankfurt Am Main, Hessen, Germany
Kai, Yamanashi, Japan
Sevilla, , Spain
Leipzig, Sachsen, Germany
Avezzano, L Aquila, Italy
Avezzano, L Aquila, Italy
Glasgow, Glasgow City, United Kingdom
Gwangju Si, Jeonranamdo, Korea, Republic Of
Glasgow, Lanarkshire, United Kingdom
Prague, , Czechia
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported