Migraine sufferers: could a new shot cut your headache days?
NCT ID NCT04921384
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called eptinezumab to see if it can prevent migraines in people with chronic migraine (15 or more headache days per month). About 981 adults took part, receiving either the drug or a placebo. The main goal was to see if the drug reduced the number of monthly migraine days over 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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981 people
The number who actually took part.
- Started
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May 2021
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The participant has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit. * 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 received any medication targeting the calcitonin gene-related peptide (CGRP) pathway as preventive treatment of migraine. * 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). Other inclusion and exclusion criteria may apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan Medical Center
Seoul, 05505, South Korea
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Atsuchi Neurosurgery Hospital
Kagoshima, 892-0842, Japan
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Aversi Clinic LTD
Tbilisi, 0160, Georgia
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Beijing Chaoyang Hospital Capital Medical University
Beijing, 100020, China
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C.H. Regional Reina Sofia - PPDS
Córdoba, 14008, Spain
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Centrum Medyczne Gdynia - PRATIA - PPDS
Gdynia, Pomeranian Voivodeship, 81-338, Poland
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Centrum Medyczne Katowice - PRATIA - PPDS
Katowice, 40-081, Poland
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Centrum Medyczne Kiepury Clinic
Sosnowiec, 41-209, Poland
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Centrum Medyczne Silmedic Sp z o o
Katowice, Silesian Voivodeship, 40-282, Poland
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Chang Gung Memorial Hospital, Linkou
Taoyuan City, 33305, Taiwan
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Chungnam National University Hospital
Daejeon, 35015, South Korea
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DOI Clinic Internal Medicine
Hirosima Naka-ku, 730-0031, Japan
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Dokkyo Medical University Hospital
Mibu-Machi, 321-0293, Japan
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ETG Lublin - PPDS
Lublin, Lublin Voivodeship, 20-412, Poland
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ETG Neuroscience - PPDS
Warsaw, Masovian Voivodeship, 02-677, Poland
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ETG Zamosc - PPDS
Zamość, Lublin Voivodeship, 22-400, Poland
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Eiju General Hospital
Taitō City, 110-8645, Japan
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Fukuuchi Pain Clinic
Shinjuku, Tokyo, 160-0017, Japan
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Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, 18450, South Korea
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Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Clinico Universitario de Valladolid
Valladolid, 47005, Spain
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Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
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Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
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Hospital Universitario HM Sanchinarro - CIOCC
Madrid, 28050, Spain
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Hospital Universitario La Paz - PPDS
Madrid, 28046, Spain
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Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 8035, Spain
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Hospital Universitario Virgen Macarena
Seville, 41009, Spain
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Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013, Spain
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IN MEDIC, s.r.o.
Bardejov, 085 01, Slovakia
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Ikeda Neurosurgical Clinic
Kasuga, 816-0824, Japan
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Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggido, 10380, South Korea
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Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
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Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-8505, Japan
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Japanese Red Cross Shizuoka Hospital
Shizuoka, 420-0853, Japan
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Jiangxi Pingxiang People's Hospital
Pingxiang, 337055, China
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Jinnouchi Neurosurgery Clinic
Kasuga-shi, 816-0802, Japan
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KONZILIUM s.r.o
Dubnica nad Váhom, 018 41, Slovakia
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Kangbuk Samsung Hospital
Seoul, 03181, South Korea
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Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
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Kitasato University Kitasato Institute Hospital
Tokyo, 108-8642, Japan
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Ltd Israel-Georgia Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
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MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210, Poland
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MTZ Clinical Research Powered by PRATIA - PPDS
Warsaw, Masovian Voivodeship, 02-172, Poland
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MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, 974 04, Slovakia
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Makabe Clinic
Okayama-Shi Kita-Ku, Okayama-ken, 700-0964, Japan
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Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha
Tbilisi, 0101, Georgia
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MediClubGeorgia Ltd
Tbilisi, 0160, Georgia
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Mito Kyodo General Hospital
Mito, 310-0015, Japan
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Moriyama Neurological Center Hospital
Edogawa-ku, Tokyo, 134-0085, Japan
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Multiprofile Clinic Consilium Medulla
Tbilisi, 0186, Georgia
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Nagamitsu Clinic
Hōfu, Yamaguchi, 7470802, Japan
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Nakamura Memorial Hospital
Sapporo-Shi Chuo-Ku, Hokkaidô, 060-0061, Japan
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Nowon Eulji Medical Center, Eulji University
Seoul, 01830, South Korea
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People's Hospital of Zhengzhou
Zhengzhou, Henan, 450003, China
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Pineo Medical Ecosystem
Tbilisi, 0114, Georgia
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Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, 430060, China
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S. Khechinashvili University Clinic, Ltd.
Tbilisi, 179, Georgia
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SANERA, s.r.o.
Prešov, 080 01, Slovakia
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Saitama Neuropsychiatric Institute
Saitama-shi, Saitama, 338-8577, Japan
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Samsung Medical Center
Seoul, 06351, South Korea
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Sendai Headache and Cranial Nerves Clinic
Sendai-Shi Taihaku-Ku, Miyagi, 982-0014, Japan
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Seoul National University Hospital
Seoul, 03080, South Korea
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Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
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Shin Matsudakai Atago Hospital
Kochi, 780-0051, Japan
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Shinagawa strings clinic
Minato-Ku, Tokyo, 108-0075, Japan
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Solumed Centrum Medyczne
Poznan, Greater Poland Voivodeship, 60-101, Poland
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Suzuki Kei Yasuragi clinic
Tachikawa-Shi, Tokyo, 190-0001, Japan
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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Tatsuoka Neurology Clinic
Kyoto Shimojo-ku, 680-8811, Japan
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The Affiliated Hospital of Guizhou Medical University
Guiyang, 550000, China
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The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Beijing, 610041, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
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The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou, Guangdong, 510120, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
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The First Hospital of Jilin University
Changchun, 130021, China
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The First Medical Center of The Chinese PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality, 100853, China
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The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus
Changchun, 130022, China
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Tokyo Dental College Ichikawa General Hospital
Ichikawa-Shi, Chiba, 272-0824, Japan
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Tokyo headache clinic
Shibuya-ku, 151-0051, Japan
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Tominaga Hospital
Naniwa-ku, 5560017, Japan
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Toyota Memorial Hospital
Toyota-shi, 471-8513, Japan
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Tri-Service General Hospital
Taipei, 11490, Taiwan
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USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, 156-0043, Japan
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Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430022, China
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Xuanwu Hospital Capital Medical University
Beijing, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Blood, tears and saliva: the hunt for Migraine's hidden signature
- Could your toothpaste be triggering migraines? trial puts it to the test
- Can sleep, neck pain, and fatigue explain Migraine's daily toll?
- Do Gender-Affirming hormones trigger headaches? thai survey probes the question
- Can a pill stop a migraine in two hours?