Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384 | Completed Phase 3

• 2 other identifiers: 19140A2020-001657-42
• Study Type: interventional
• Target: 981
• Locations: 8 countries
• Sites: 87

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

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

  Weeks 1-12

Secondary Outcomes (17)

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

  Weeks 1-12

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

  Weeks 1-4

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

  Weeks 1-12

• Migraine rate on the day after dosing

  Day 1

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

  Weeks 1-12

Study Arms (3)

Eptinezumab 300 mg

EXPERIMENTAL

300 mg eptinezumab by intravenous (IV) infusion.

Drug: Eptinezumab

Eptinezumab 100 mg

EXPERIMENTAL

100 mg eptinezumab by IV infusion.

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

Placebo by IV infusion.

Drug: Placebo; Drug: Eptinezumab

Interventions

Eptinezumab DRUG

Solution for infusion, intravenously

Also known as: Lu AG09221

Eptinezumab 100 mg; Eptinezumab 300 mg; Placebo

Placebo DRUG

0.9% normal saline, intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (87)

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

Beijing, Beijing Municipality, 100853, China

Location

The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus

Guangzhou, Guangdong, 510120, China

Location

People's Hospital of Zhengzhou

Zhengzhou, Henan, 450003, China

Location

Renmin Hospital of Wuhan University - Main Campus

Wuhan, Hubei, 430060, China

Location

Beijing Chaoyang Hospital Capital Medical University

Beijing, 100020, China

Location

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

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

Beijing, 610041, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus

Changchun, 130022, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, 550000, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, 337055, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha

Tbilisi, 0101, Georgia

Location

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

Location

Aversi Clinic LTD

Tbilisi, 0160, Georgia

Location

MediClubGeorgia Ltd

Tbilisi, 0160, Georgia

Location

Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

S. Khechinashvili University Clinic, Ltd.

Tbilisi, 179, Georgia

Location

Tokyo Dental College Ichikawa General Hospital

Ichikawa-Shi, Chiba, 272-0824, Japan

Location

Nakamura Memorial Hospital

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

Location

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-8505, Japan

Location

Sendai Headache and Cranial Nerves Clinic

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

Location

Makabe Clinic

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

Location

Saitama Neuropsychiatric Institute

Saitama-shi, Saitama, 338-8577, Japan

Location

Moriyama Neurological Center Hospital

Edogawa-ku, Tokyo, 134-0085, Japan

Location

Shinagawa strings clinic

Minato-Ku, Tokyo, 108-0075, Japan

Location

USUDA CLINIC for internal medicine

Setagaya-ku, Tokyo, 156-0043, Japan

Location

Fukuuchi Pain Clinic

Shinjuku, Tokyo, 160-0017, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

Suzuki Kei Yasuragi clinic

Tachikawa-Shi, Tokyo, 190-0001, Japan

Location

Nagamitsu Clinic

Hōfu, Yamaguchi, 7470802, Japan

Location

DOI Clinic Internal Medicine

Hirosima Naka-ku, 730-0031, Japan

Location

Atsuchi Neurosurgery Hospital

Kagoshima, 892-0842, Japan

Location

Ikeda Neurosurgical Clinic

Kasuga, 816-0824, Japan

Location

Jinnouchi Neurosurgery Clinic

Kasuga-shi, 816-0802, Japan

Location

Shin Matsudakai Atago Hospital

Kochi, 780-0051, Japan

Location

Tatsuoka Neurology Clinic

Kyoto Shimojo-ku, 680-8811, Japan

Location

Dokkyo Medical University Hospital

Mibu-Machi, 321-0293, Japan

Location

Mito Kyodo General Hospital

Mito, 310-0015, Japan

Location

Tominaga Hospital

Naniwa-ku, 5560017, Japan

Location

Tokyo headache clinic

Shibuya-ku, 151-0051, Japan

Location

Japanese Red Cross Shizuoka Hospital

Shizuoka, 420-0853, Japan

Location

Eiju General Hospital

Taitō City, 110-8645, Japan

Location

Kitasato University Kitasato Institute Hospital

Tokyo, 108-8642, Japan

Location

Toyota Memorial Hospital

Toyota-shi, 471-8513, Japan

Location

Solumed Centrum Medyczne

Poznan, Greater Poland Voivodeship, 60-101, Poland

Location

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

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

ETG Lublin - PPDS

Lublin, Lublin Voivodeship, 20-412, Poland

Location

ETG Zamosc - PPDS

Zamość, Lublin Voivodeship, 22-400, Poland

Location

MTZ Clinical Research Powered by PRATIA - PPDS

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

ETG Neuroscience - PPDS

Warsaw, Masovian Voivodeship, 02-677, Poland

Location

Centrum Medyczne Gdynia - PRATIA - PPDS

Gdynia, Pomeranian Voivodeship, 81-338, Poland

Location

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship, 40-282, Poland

Location

Centrum Medyczne Katowice - PRATIA - PPDS

Katowice, 40-081, Poland

Location

Centrum Medyczne Kiepury Clinic

Sosnowiec, 41-209, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, 52-210, Poland

Location

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

Banská Bystrica, 974 04, Slovakia

Location

IN MEDIC, s.r.o.

Bardejov, 085 01, Slovakia

Location

KONZILIUM s.r.o

Dubnica nad Váhom, 018 41, Slovakia

Location

SANERA, s.r.o.

Prešov, 080 01, Slovakia

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggido, 10380, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, 18450, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

C.H. Regional Reina Sofia - PPDS

Córdoba, 14008, Spain

Location

Hospital Universitari Arnau de Vilanova

Lleida, 25198, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Hospital Universitario HM Sanchinarro - CIOCC

Madrid, 28050, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 41091746 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: May 29, 2021
• Primary Completion: October 1, 2024
• Study Completion: February 17, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

SL (4); ES (11); CN (15); JP (27); GE (7); KR (9); PL (11); TW (3)