Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Migraine Clinical Trial

— Sunrise  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04921384
• Other study ID #: 19140A
• Secondary ID: 2020-001657-42
• Status: Recruiting
• Phase: Phase 3
• Start date: May 29, 2021
• Est. completion date: March 11, 2025

Study information

• Verified date: December 2023
• Source: H. Lundbeck A/S
• Contact: Email contact via H. Lundbeck A/S
• Phone: +45 36301311
• Email: LundbeckClinicalTrials[@]Lundbeck.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 945
• Est. completion date: March 11, 2025
• Est. primary completion date: October 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Placebo
0.9% normal saline, intravenously
• Eptinezumab
Solution for infusion, intravenously

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital Capital Medical University	Beijing
China	Chinese PLA General Hospital	Beijing
China	Jiangsu Province Hospital (The First Affiliated Hospital With Nanjing Medical University)	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	The First Hospital of Jilin University	Changchun
China	The Second Hospital of Jilin University	Changchun
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang
China	Jiangxi Pingxiang People's Hospital	Pingxiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
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	People's Hospital of Zhengzhou	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Georgia	Aversi Clinic LTD	Tbilisi
Georgia	Ltd Israel-Georgia Medical Research Clinic Helsicore	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha	Tbilisi
Georgia	MediClubGeorgia Ltd	Tbilisi
Georgia	Multiprofile Clinic Consilium Medulla".	Tbilisi
Georgia	Pineo Medical Ecosystem	Tbilisi
Georgia	S. Khechinashvili University Clinic, Ltd.	Tbilisi
Japan	Moriyama Neurological Center Hospital	Edogawa-ku	Tokyo
Japan	DOI Clinic Internal Medicine	Hirosima Naka-ku
Japan	Nagamitsu Clinic	Hofu	Yamaguti
Japan	Tokyo Dental College Ichikawa General Hospital	Ichikawa-Shi	Tiba
Japan	Atsuchi Neurosurgery Hospital	Kagoshima-shi
Japan	Ikeda Neurosurgical Clinic	Kasuga City
Japan	Jinnouchi Neurosurgery Clinic	Kasuga-shi
Japan	Shin Matsudakai Atago Hospital	Kochi-shi
Japan	Tatsuoka Neurology Clinic	Kyoto Shimojo-ku
Japan	Dokkyo Medical University Hospital	Mibu-Machi
Japan	Shinagawa strings clinic	Minato-Ku	Tokyo
Japan	Mito Kyodo General Hospital	Mito-shi
Japan	Iwate Medical University Uchimaru Medical Center	Morioka	Iwate
Japan	Tominaga Hospital	Naniwa-ku
Japan	Makabe Clinic	Okayama-Shi Kita-Ku	Okayama
Japan	Saitama Neuropsychiatric Institute	Saitama-shi	Saitama
Japan	Nakamura Memorial Hospital	Sapporo-Shi Chuo-Ku	Hokkaidô
Japan	Sendai Headache and Cranial Nerves Clinic	Sendai-Shi Taihaku-Ku	Miyagi
Japan	USUDA CLINIC for internal medicine	Setagaya-ku	Tokyo
Japan	Tokyo headache clinic	Shibuya-ku
Japan	Fukuuchi Pain Clinic	Shinjuku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi
Japan	Eiju General Hospital	Taito City
Japan	Kitasato University Kitasato Institute Hospital	Tokyo
Japan	Toyota Memorial Hospital	Toyota-shi
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang-si	Gyeonggido
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Poland	Centrum Medyczne Gdynia - PRATIA - PPDS	Gdynia	Pomorskie
Poland	Centrum Medyczne Katowice - PRATIA - PPDS	Katowice
Poland	Centrum Medyczne Silmedic Sp z o o	Katowice	Slaskie
Poland	ETG Lublin - PPDS	Lublin	Lubelskie
Poland	Instytut Zdrowia Dr Boczarska-Jedynak	Oswiecim	Malopolskie
Poland	Solumed SC-Dabrowskiego 77a	Poznan	Wielkopolskie
Poland	Kiepury Clinic	Sosnowiec
Poland	ETG Singua - PPDS	Warszawa	Mazowieckie
Poland	MTZ Clinical Research Powered by PRATIA - PPDS	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw
Poland	ETG Zamosc - PPDS	Zamosc	Lubelskie
Slovakia	MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.	Banska Bystrica
Slovakia	IN MEDIC, s.r.o.	Bardejov
Slovakia	KONZILIUM s.r.o	Dubnica nad Vahom
Slovakia	SANERA, s.r.o.	Presov
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	C.H. Regional Reina Sofia - PPDS	Cordoba
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital Universitario HM Sanchinarro - CIOCC	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Virgen del Rocio - PPDS	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
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
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

China,  Georgia,  Japan,  Korea, Republic of,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)		Weeks 1-12
Secondary	Response: =50% reduction from baseline in MMDs (Weeks 1-12)		Weeks 1-12
Secondary	Response: =75% reduction from baseline in MMDs (Weeks 1-4)		Weeks 1-4
Secondary	Response: =75% reduction from baseline in MMDs, (Weeks 1-12)		Weeks 1-12
Secondary	Migraine rate on the day after dosing		Day 1
Secondary	Response: =50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12)		Weeks 1-12
Secondary	Change from baseline in the number of MHDs (Weeks 1-12)		Weeks 1-12
Secondary	Response: =75% reduction from baseline in MHDs (Weeks 1-4)		Weeks 1-4
Secondary	Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12)		Weeks 1-12
Secondary	Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12)		Weeks 1-12
Secondary	Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12)		Weeks 1-12
Secondary	Patient Global Impression of Change (PGIC) score at week 12		Week 12
Secondary	Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening		Screening to Week 12
Secondary	Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score		Baseline to Week 12
Secondary	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)		Baseline to Week 12
Secondary	Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score		Baseline to Week 12
Secondary	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.	Baseline to Week 12
Secondary	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)		Baseline to Week 12