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MigrainePhase 3SunriseNCT04921384

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 87 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
981 participants
Where
87 sitesin 8 countries
Study dates
29 May 2021to 17 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

87 sites in 8 countries.

87 sites in 8 countries

Japan27 sites

  • Moriyama Neurological Center Hospital

    Edogawa-ku, Tokyo, 134-0085

  • DOI Clinic Internal Medicine

    Hirosima Naka-ku, 730-0031

  • Nagamitsu Clinic

    Hōfu, Yamaguchi, 7470802

  • Tokyo Dental College Ichikawa General Hospital

    Ichikawa-Shi, Chiba, 272-0824

  • Atsuchi Neurosurgery Hospital

    Kagoshima, 892-0842

  • Ikeda Neurosurgical Clinic

    Kasuga, 816-0824

  • Jinnouchi Neurosurgery Clinic

    Kasuga-shi, 816-0802

  • Shin Matsudakai Atago Hospital

    Kochi, 780-0051

  • Tatsuoka Neurology Clinic

    Kyoto Shimojo-ku, 680-8811

  • Dokkyo Medical University Hospital

    Mibu-Machi, 321-0293

  • Shinagawa strings clinic

    Minato-Ku, Tokyo, 108-0075

  • Mito Kyodo General Hospital

    Mito, 310-0015

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505

  • Tominaga Hospital

    Naniwa-ku, 5560017

  • Makabe Clinic

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

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577

  • Nakamura Memorial Hospital

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

  • Sendai Headache and Cranial Nerves Clinic

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

  • USUDA CLINIC for internal medicine

    Setagaya-ku, Tokyo, 156-0043

  • Tokyo headache clinic

    Shibuya-ku, 151-0051

  • Fukuuchi Pain Clinic

    Shinjuku, Tokyo, 160-0017

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, 420-0853

  • Suzuki Kei Yasuragi clinic

    Tachikawa-Shi, Tokyo, 190-0001

  • Eiju General Hospital

    Taitō City, 110-8645

  • Kitasato University Kitasato Institute Hospital

    Tokyo, 108-8642

  • Toyota Memorial Hospital

    Toyota-shi, 471-8513

Other trials in Japan

China15 sites

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

    Beijing, Beijing Municipality, 100853

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

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

    Beijing, 610041

  • The First Hospital of Jilin University

    Changchun, 130021

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

    Changchun, 130022

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

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

    Guangzhou, Guangdong, 510120

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550000

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, 337055

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, Hubei, 430060

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

    Wuhan, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Poland11 sites

  • Centrum Medyczne Gdynia - PRATIA - PPDS

    Gdynia, Pomeranian Voivodeship, 81-338

  • Centrum Medyczne Silmedic Sp z o o

    Katowice, Silesian Voivodeship, 40-282

  • Centrum Medyczne Katowice - PRATIA - PPDS

    Katowice, 40-081

  • ETG Lublin - PPDS

    Lublin, Lublin Voivodeship, 20-412

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

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Solumed Centrum Medyczne

    Poznan, Greater Poland Voivodeship, 60-101

  • Centrum Medyczne Kiepury Clinic

    Sosnowiec, 41-209

  • MTZ Clinical Research Powered by PRATIA - PPDS

    Warsaw, Masovian Voivodeship, 02-172

  • ETG Neuroscience - PPDS

    Warsaw, Masovian Voivodeship, 02-677

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, 52-210

  • ETG Zamosc - PPDS

    Zamość, Lublin Voivodeship, 22-400

Other trials in Poland

Spain11 sites

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

  • C.H. Regional Reina Sofia - PPDS

    Córdoba, 14008

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

South Korea9 sites

  • Chungnam National University Hospital

    Daejeon, 35015

  • Inje University Ilsan Paik Hospital

    Goyang-si, Gyeonggido, 10380

  • Hallym University Dongtan Sacred Heart Hospital

    Gyeonggi-do, 18450

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Georgia7 sites

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha

    Tbilisi, 0101

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112

  • Pineo Medical Ecosystem

    Tbilisi, 0114

  • Aversi Clinic LTD

    Tbilisi, 0160

  • MediClubGeorgia Ltd

    Tbilisi, 0160

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

  • S. Khechinashvili University Clinic, Ltd.

    Tbilisi, 179

Other trials in Georgia

Slovakia4 sites

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

    Banská Bystrica, 974 04

  • IN MEDIC, s.r.o.

    Bardejov, 085 01

  • KONZILIUM s.r.o

    Dubnica nad Váhom, 018 41

  • SANERA, s.r.o.

    Prešov, 080 01

Other trials in Slovakia

Taiwan3 sites

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

About this study

Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

Read the detailed description

This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment.

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
Migraine
Being tested
Placebo, Eptinezumab
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    0.9% normal saline, intravenously

  • EptinezumabDrug

    Also called Lu AG09221

    Solution for infusion, intravenously

Study groups in NCT04921384
Study groupRoleWhat they receive
Eptinezumab 300 mgExperimental300 mg eptinezumab by intravenous (IV) infusion.
Receives: Drug: Eptinezumab
Eptinezumab 100 mgExperimental100 mg eptinezumab by IV infusion.
Receives: Drug: Eptinezumab
PlaceboPlacebo comparatorPlacebo by IV infusion.
Receives: Drug: Placebo; Drug: Eptinezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)

    Measured: Weeks 1-12

Secondary outcomes (17)

  1. Response: ≥50% reduction from baseline in MMDs (Weeks 1-12)

    Measured: Weeks 1-12

  2. Response: ≥75% reduction from baseline in MMDs (Weeks 1-4)

    Measured: Weeks 1-4

  3. Response: ≥75% reduction from baseline in MMDs, (Weeks 1-12)

    Measured: Weeks 1-12

  4. Migraine rate on the day after dosing

    Measured: Day 1

  5. Response: ≥50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12)

    Measured: Weeks 1-12

  6. Change from baseline in the number of MHDs (Weeks 1-12)

    Measured: Weeks 1-12

  7. Response: ≥75% reduction from baseline in MHDs (Weeks 1-4)

    Measured: Weeks 1-4

  8. Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12)

    Measured: Weeks 1-12

  9. Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12)

    Measured: Weeks 1-12

  10. Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12)

    Measured: Weeks 1-12

  11. Patient Global Impression of Change (PGIC) score at week 12

    Measured: Week 12

  12. Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening

    Measured: Screening to Week 12

  13. Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score

    Measured: Baseline to Week 12

  14. Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function)

    Measured: Baseline to Week 12

  15. Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score

    Measured: Baseline to Week 12

  16. Health Care Resources Utilization (HCRU)

    Migraine-specific healthcare resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays.

    Measured: Baseline to Week 12

  17. Change from baseline to Week 12 in the Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start29 May 2021
  3. Primary completion1 Oct 2024
  4. Study completion17 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
981 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04921384
Sponsor's protocol ID
19140A
Other IDs
2020-001657-42
Acronym
Sunrise
Status last verified
Jan 2026
First submitted
4 Jun 2021
Last updated
14 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41091746

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 87 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in Japan, China, Poland, Spain, South Korea and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12) (time frame: Weeks 1-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04921384, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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