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Migraine sufferers: could a new shot cut your headache days?

NCT ID NCT04921384

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

981 people

The number who actually took part.

Started

May 2021

Finished

Feb 2025

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Atsuchi Neurosurgery Hospital

    Kagoshima, 892-0842, Japan

  • Aversi Clinic LTD

    Tbilisi, 0160, Georgia

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020, China

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14008, Spain

  • Centrum Medyczne Gdynia - PRATIA - PPDS

    Gdynia, Pomeranian Voivodeship, 81-338, Poland

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, 40-081, Poland

  • Centrum Medyczne Kiepury Clinic

    Sosnowiec, 41-209, Poland

  • Centrum Medyczne Silmedic Sp z o o

    Katowice, Silesian Voivodeship, 40-282, Poland

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305, Taiwan

  • Chungnam National University Hospital

    Daejeon, 35015, South Korea

  • DOI Clinic Internal Medicine

    Hirosima Naka-ku, 730-0031, Japan

  • Dokkyo Medical University Hospital

    Mibu-Machi, 321-0293, Japan

  • ETG Lublin - PPDS

    Lublin, Lublin Voivodeship, 20-412, Poland

  • ETG Neuroscience - PPDS

    Warsaw, Masovian Voivodeship, 02-677, Poland

  • ETG Zamosc - PPDS

    Zamość, Lublin Voivodeship, 22-400, Poland

  • Eiju General Hospital

    Taitō City, 110-8645, Japan

  • Fukuuchi Pain Clinic

    Shinjuku, Tokyo, 160-0017, Japan

  • Hallym University Dongtan Sacred Heart Hospital

    Gyeonggi-do, 18450, South Korea

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005, Spain

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026, Spain

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050, Spain

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013, Spain

  • IN MEDIC, s.r.o.

    Bardejov, 085 01, Slovakia

  • Ikeda Neurosurgical Clinic

    Kasuga, 816-0824, Japan

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggido, 10380, South Korea

  • Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505, Japan

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, 420-0853, Japan

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, 337055, China

  • Jinnouchi Neurosurgery Clinic

    Kasuga-shi, 816-0802, Japan

  • KONZILIUM s.r.o

    Dubnica nad Váhom, 018 41, Slovakia

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642, Japan

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112, Georgia

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210, Poland

  • MTZ Clinical Research Powered by PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

    Banská Bystrica, 974 04, Slovakia

  • Makabe Clinic

    Okayama-Shi Kita-Ku, Okayama-ken, 700-0964, Japan

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha

    Tbilisi, 0101, Georgia

  • MediClubGeorgia Ltd

    Tbilisi, 0160, Georgia

  • Mito Kyodo General Hospital

    Mito, 310-0015, Japan

  • Moriyama Neurological Center Hospital

    Edogawa-ku, Tokyo, 134-0085, Japan

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • Nagamitsu Clinic

    Hōfu, Yamaguchi, 7470802, Japan

  • Nakamura Memorial Hospital

    Sapporo-Shi Chuo-Ku, Hokkaidô, 060-0061, Japan

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830, South Korea

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003, China

  • Pineo Medical Ecosystem

    Tbilisi, 0114, Georgia

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, Hubei, 430060, China

  • S. Khechinashvili University Clinic, Ltd.

    Tbilisi, 179, Georgia

  • SANERA, s.r.o.

    Prešov, 080 01, Slovakia

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sendai Headache and Cranial Nerves Clinic

    Sendai-Shi Taihaku-Ku, Miyagi, 982-0014, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shin Matsudakai Atago Hospital

    Kochi, 780-0051, Japan

  • Shinagawa strings clinic

    Minato-Ku, Tokyo, 108-0075, Japan

  • Solumed Centrum Medyczne

    Poznan, Greater Poland Voivodeship, 60-101, Poland

  • Suzuki Kei Yasuragi clinic

    Tachikawa-Shi, Tokyo, 190-0001, Japan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tatsuoka Neurology Clinic

    Kyoto Shimojo-ku, 680-8811, Japan

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550000, China

  • The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)

    Beijing, 610041, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016, China

  • The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The First Medical Center of The Chinese PLA General Hospital (301 Hospital)

    Beijing, Beijing Municipality, 100853, China

  • The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus

    Changchun, 130022, China

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa-Shi, Chiba, 272-0824, Japan

  • Tokyo headache clinic

    Shibuya-ku, 151-0051, Japan

  • Tominaga Hospital

    Naniwa-ku, 5560017, Japan

  • Toyota Memorial Hospital

    Toyota-shi, 471-8513, Japan

  • Tri-Service General Hospital

    Taipei, 11490, Taiwan

  • USUDA CLINIC for internal medicine

    Setagaya-ku, Tokyo, 156-0043, Japan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.