Oral atogepant tablets for treating migraine attacks in adults

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)

This study will test whether oral atogepant tablets can quickly treat migraine attacks in adults aged 18-75 with episodic migraine.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 149 sites (Edegem, Antwerpen and 148 other locations)
• Trial ID: NCT06241313 on ClinicalTrials.gov

What this trial studies

This Phase 3 randomized, double-blind, placebo-controlled study enrolls about 1,300 adults aged 18-75 with episodic migraine to compare single-attack treatment with oral atogepant versus placebo, followed by an open-label phase in which all participants receive atogepant. Participants must have a 12-month history of migraine and 2-8 moderate-to-severe migraine attacks per month, while those with chronic migraine or frequent ER visits are excluded. Primary outcomes include rapid pain relief for treated attacks, overall safety, and tolerability during the blinded and open-label periods. The trial is being conducted at roughly 160 sites, including university hospitals in Belgium, and requires participants to attend scheduled clinic visits for dosing and monitoring.

Who should consider this trial

Good fit: Adults 18-75 with a ≥12-month history of migraine who experience 2-8 moderate-to-severe migraine attacks per month and can attend visits at a participating site are ideal candidates.

Not a fit: People with chronic migraine (about ≥15 headache days per month), those with frequent recent ER-level attacks, or those unable to attend site visits are unlikely to qualify or benefit from this acute-use study.

Why it matters

Potential benefit: If successful, atogepant could give adults with episodic migraine an effective, well-tolerated oral option to stop attacks quickly.

How similar studies have performed: Other gepant drugs have shown success when used acutely, and atogepant is already approved for preventive use, but applying atogepant specifically for rapid treatment of individual attacks is a less-tested approach.

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.

Where this trial is running

Edegem, Antwerpen and 148 other locations

• Universitair Ziekenhuis Antwerpen /ID# 257582 — Edegem, Antwerpen, Belgium (Active_not_recruiting)
• Universitair Ziekenhuis Brussel /ID# 257584 — Jette, Brussels Capital, Belgium (Recruiting)
• Cabinet Prive Dr Sava /ID# 257581 — Saint-Nicolas, Liege, Belgium (Recruiting)
• Jessa Ziekenhuis /ID# 257578 — Hasselt, Limburg, Belgium (Active_not_recruiting)
• AZ Sint-Jan Brugge /ID# 257585 — Bruges, West-Vlaanderen, Belgium (Active_not_recruiting)
• AZ Groeninge /ID# 257586 — Kortrijk, Belgium (Recruiting)
• H.-Hartziekenhuis Lier /ID# 257577 — Lier, Belgium (Recruiting)
• CHR de la Citadelle /ID# 257587 — Liège, Belgium (Recruiting)
• The first affiliated hospital of bengbu medical college /ID# 258758 — Bengbu, Anhui, China (Completed)
• Beijing Friendship Hospital /ID# 258830 — Beijing, Beijing Municipality, China (Completed)
• Xuanwu Hospital Capital Medical University /ID# 258510 — Beijing, Beijing Municipality, China (Completed)
• Peking University Third Hospital /ID# 259573 — Beijing, Beijing Municipality, China (Completed)
• Chinese PLA General Hospital /ID# 257540 — Beijing, Beijing Municipality, China (Completed)
• Peking University First Hospital /ID# 258672 — Xicheng District, Beijing Municipality, China (Completed)
• Fujian Medical University Union Hospital /ID# 259575 — Fuzhou, Fujian, China (Completed)
• The First Affiliated Hospital of Xiamen University /ID# 259576 — Xiamen, Fujian, China (Completed)
• Lanzhou University Second Hospital /ID# 259667 — Lanzhou, Gansu, China (Completed)
• Guangzhou First People's Hospital /ID# 258656 — Guangzhou, Guangdong, China (Completed)
• The Second Affiliated Hospital of Guangzhou Medical University /ID# 258638 — Guangzhou, Guangdong, China (Completed)
• The University Of Hong Kong - Shenzhen Hospital /ID# 258462 — Shenzhen, Guangdong, China (Completed)
• The Affiliated Hospital of Guizhou Medical University /ID# 259536 — Guiyang, Guizhou, China (Completed)
• Hainan General Hospital /ID# 259548 — Haikou, Hainan, China (Completed)
• Hebei General Hospital /ID# 258583 — Shijiazhuang, Hebei, China (Completed)
• Zhengzhou People's Hospital /ID# 258670 — Zhengzhou, Henan, China (Completed)
• The Second Xiangya Hospital Of Central South University /ID# 260623 — Changsha, Hunan, China (Completed)
• The Third Xiangya Hospital of Central South University /ID# 258787 — Changsha, Hunan, China (Completed)
• Zhuzhou Central Hospital /ID# 260076 — Zhuzhou, Hunan, China (Completed)
• The Second Affiliated Hospital of Nanjing Medical University /ID# 258648 — Nanjing, Jiangsu, China (Completed)
• The Second Affiliated Hospital of Soochow University /ID# 259551 — Suzhou, Jiangsu, China (Completed)
• The First Affiliated Hospital of Soochow University /ID# 258783 — Suzhou, Jiangsu, China (Completed)
• Jiangxi Pingxiang Peoples Hospital /ID# 258652 — Pingxiang, Jiangxi, China (Completed)
• The First Hospital of Jilin University /ID# 259585 — Changchun, Jilin, China (Completed)
• The Second hospital of Jilin university /ID# 258556 — Changchun, Jilin, China (Completed)
• General Hospital of Northern Theater Command /ID# 259556 — Shenyang, Liaoning, China (Completed)
• Shaanxi Provincial PeopleS Hospital /ID# 259529 — Xi'an, Shaanxi, China (Completed)
• Second Hospital of Shanxi Medical University /ID# 259669 — Taiyuan, Shanxi, China (Completed)
• West China Hospital, Sichuan University /ID# 258664 — Chengdu, Sichuan, China (Completed)
• Tianjin Medical University General Hospital /ID# 259513 — Tianjin, Tianjin Municipality, China (Completed)
• Tianjin People's Hospital /ID# 258625 — Tianjin, Tianjin Municipality, China (Completed)
• The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 258860 — Hangzhou, Zhejiang, China (Completed)
• The First Affiliated Hospital of Wenzhou Medical University /ID# 258939 — Wenzhou, Zhejiang, China (Completed)
• Baotou Central Hospital /ID# 258786 — Baotou, China (Completed)
• The first people's Hospital Affiliated to Shanghai Jiaotong University /ID# 259554 — Shanghai, China (Completed)
• CCR Ostrava, s.r.o. /ID# 257743 — Ostrava, Ostrava-mesto, Czechia (Recruiting)
• Fakultni Nemocnice Ostrava /ID# 259023 — Ostrava, Ostrava-mesto, Czechia (Recruiting)
• Praglandia /ID# 257667 — Prague, Praha 5, Czechia (Recruiting)
• NeuroHK s.r.o. /ID# 257671 — Hradec Králové, Czechia (Recruiting)
• Clintrial s.r.o. /ID# 257663 — Prague, Czechia (Recruiting)
• DADO MEDICAL s.r.o. /ID# 257672 — Prague, Czechia (Recruiting)
• Axon Clinical, s.r.o. /ID# 259024 — Prague, Czechia (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Migraine; Atogepant; ECLIPSE; Qulipta; Aquipta