Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
NCT ID: NCT04921384
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
981 participants
INTERVENTIONAL
2021-05-29
2025-02-17
Brief Summary
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Detailed Description
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participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo.
The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab.
The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Eptinezumab 300 mg
300 mg eptinezumab by intravenous (IV) infusion.
Eptinezumab
Solution for infusion, intravenously
Eptinezumab 100 mg
100 mg eptinezumab by IV infusion.
Eptinezumab
Solution for infusion, intravenously
Placebo
Placebo by IV infusion.
Placebo
0.9% normal saline, intravenously
Eptinezumab
Solution for infusion, intravenously
Interventions
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Placebo
0.9% normal saline, intravenously
Eptinezumab
Solution for infusion, intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The participant has a migraine onset at ≤50 years of age.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period:
* Migraine occurring on ≥8 days and headache occurring on ≥15 to ≤26 days.
* The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
* The participant is aged ≥18 (≥20 for Taiwan) and ≤75 years at the Screening Visit.
Exclusion Criteria
* The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
* The participant has a diagnosis of acute or active temporomandibular disorder.
* The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
* The participant has a lifetime history of psychosis, bipolar mania, or dementia.
* Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded.
* The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
18 Years
75 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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The First Medical Center of The Chinese PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou, Guangdong, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, , China
Xuanwu Hospital Capital Medical University
Beijing, , China
The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus
Changchun, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
The Affiliated Hospital of Guizhou Medical University
Guiyang, , China
Jiangxi Pingxiang People's Hospital
Pingxiang, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha
Tbilisi, , Georgia
Ltd Israel-Georgia Medical Research Clinic Helsicore
Tbilisi, , Georgia
Pineo Medical Ecosystem
Tbilisi, , Georgia
Aversi Clinic LTD
Tbilisi, , Georgia
MediClubGeorgia Ltd
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla
Tbilisi, , Georgia
S. Khechinashvili University Clinic, Ltd.
Tbilisi, , Georgia
Tokyo Dental College Ichikawa General Hospital
Ichikawa-Shi, Chiba, Japan
Nakamura Memorial Hospital
Sapporo-Shi Chuo-Ku, Hokkaidô, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, Japan
Sendai Headache and Cranial Nerves Clinic
Sendai-Shi Taihaku-Ku, Miyagi, Japan
Makabe Clinic
Okayama-Shi Kita-Ku, Okayama-ken, Japan
Saitama Neuropsychiatric Institute
Saitama-shi, Saitama, Japan
Moriyama Neurological Center Hospital
Edogawa-ku, Tokyo, Japan
Shinagawa strings clinic
Minato-Ku, Tokyo, Japan
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, Japan
Fukuuchi Pain Clinic
Shinjuku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Suzuki Kei Yasuragi clinic
Tachikawa-Shi, Tokyo, Japan
Nagamitsu Clinic
Hōfu, Yamaguchi, Japan
DOI Clinic Internal Medicine
Hirosima Naka-ku, , Japan
Atsuchi Neurosurgery Hospital
Kagoshima, , Japan
Ikeda Neurosurgical Clinic
Kasuga, , Japan
Jinnouchi Neurosurgery Clinic
Kasuga-shi, , Japan
Shin Matsudakai Atago Hospital
Kochi, , Japan
Tatsuoka Neurology Clinic
Kyoto Shimojo-ku, , Japan
Dokkyo Medical University Hospital
Mibu-Machi, , Japan
Mito Kyodo General Hospital
Mito, , Japan
Tominaga Hospital
Naniwa-ku, , Japan
Tokyo headache clinic
Shibuya-ku, , Japan
Japanese Red Cross Shizuoka Hospital
Shizuoka, , Japan
Eiju General Hospital
Taitō City, , Japan
Kitasato University Kitasato Institute Hospital
Tokyo, , Japan
Toyota Memorial Hospital
Toyota-shi, , Japan
Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Lesser Poland Voivodeship, Poland
ETG Lublin - PPDS
Lublin, Lublin Voivodeship, Poland
ETG Zamosc - PPDS
Zamość, Lublin Voivodeship, Poland
MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, Poland
ETG Neuroscience - PPDS
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Gdynia - PRATIA - PPDS
Gdynia, Pomeranian Voivodeship, Poland
Centrum Medyczne Silmedic Sp z o o
Katowice, Silesian Voivodeship, Poland
Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, , Poland
Centrum Medyczne Kiepury Clinic
Sosnowiec, , Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, , Poland
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, , Slovakia
IN MEDIC, s.r.o.
Bardejov, , Slovakia
KONZILIUM s.r.o
Dubnica nad Váhom, , Slovakia
SANERA, s.r.o.
Prešov, , Slovakia
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggido, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, , South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
C.H. Regional Reina Sofia - PPDS
Córdoba, , Spain
Hospital Universitari Arnau de Vilanova
Lleida, , Spain
Hospital Universitario La Paz - PPDS
Madrid, , Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Countries
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References
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Yu S, Matsumori Y, Kim BK, Gryglas-Dworak A, Giorgadze G, Pozo-Rosich P, Krog Josiassen M, Ranc K, Ettrup A, Mittoux A, Sperling B, Takeshima T. Efficacy and safety of eptinezumab in a predominantly Asian population with chronic migraine: Results of the randomized, double-blind, placebo-controlled SUNRISE trial. Cephalalgia. 2025 Oct;45(10):3331024251386095. doi: 10.1177/03331024251386095. Epub 2025 Oct 15.
Other Identifiers
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2020-001657-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19140A
Identifier Type: -
Identifier Source: org_study_id
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