Clinical trial NCT04921384: Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-06-10
Enrollment: 981
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)
timeFrame: Weeks 1-12
Secondary outcomes:
measure: Response: ≥50% reduction from baseline in MMDs (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Response: ≥75% reduction from baseline in MMDs (Weeks 1-4)
timeFrame: Weeks 1-4
measure: Response: ≥75% reduction from baseline in MMDs, (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Migraine rate on the day after dosing
timeFrame: Day 1
measure: Response: ≥50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Change from baseline in the number of MHDs (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Response: ≥75% reduction from baseline in MHDs (Weeks 1-4)
timeFrame: Weeks 1-4
measure: Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12)
timeFrame: Weeks 1-12
measure: Patient Global Impression of Change (PGIC) score at week 12
timeFrame: Week 12
measure: Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening
timeFrame: Screening to Week 12
measure: Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score
timeFrame: Baseline to Week 12
measure: 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)
timeFrame: Baseline to Week 12
measure: Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
timeFrame: Baseline to Week 12
measure: Health Care Resources Utilization (HCRU)
timeFrame: Baseline to Week 12
measure: 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)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Medical Center of The Chinese PLA General Hospital (301 Hospital)
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
state: Guangdong
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University - Main Campus
state: Hubei
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center -3 Nakalakevis Kucha
city: Tbilisi
country: Georgia
facility: Ltd Israel-Georgia Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem
city: Tbilisi
country: Georgia
facility: Aversi Clinic LTD
city: Tbilisi
country: Georgia
facility: MediClubGeorgia Ltd
city: Tbilisi
country: Georgia
facility: Multiprofile Clinic Consilium Medulla
city: Tbilisi
country: Georgia
facility: S. Khechinashvili University Clinic, Ltd.
city: Sapporo-Shi Chuo-Ku
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaidô
city: Morioka
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Sendai-Shi Taihaku-Ku
country: Japan
facility: Sendai Headache and Cranial Nerves Clinic
state: Miyagi
city: Okayama-Shi Kita-Ku
country: Japan
facility: Makabe Clinic
state: Okayama
city: Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Ichikawa-Shi
country: Japan
facility: Tokyo Dental College Ichikawa General Hospital
state: Tiba
city: Edogawa-ku
country: Japan
facility: Moriyama Neurological Center Hospital
state: Tokyo
city: Minato-Ku
country: Japan
facility: Shinagawa strings clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: USUDA CLINIC for internal medicine
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku
country: Japan
facility: Fukuuchi Pain Clinic
state: Tokyo
city: Tachikawa-Shi
country: Japan
facility: Suzuki Kei Yasuragi clinic
state: Tokyo
city: Hofu
country: Japan
facility: Nagamitsu Clinic
state: Yamaguti
city: Hirosima Naka-ku
country: Japan
facility: DOI Clinic Internal Medicine
city: Kagoshima-shi
country: Japan
facility: Atsuchi Neurosurgery Hospital
city: Kasuga City
country: Japan
facility: Ikeda Neurosurgical Clinic
city: Kasuga-shi
country: Japan
facility: Jinnouchi Neurosurgery Clinic
city: Kochi-shi
country: Japan
facility: Shin Matsudakai Atago Hospital
city: Kyoto Shimojo-ku
country: Japan
facility: Tatsuoka Neurology Clinic
city: Mibu-Machi
country: Japan
facility: Dokkyo Medical University Hospital
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital
city: Naniwa-ku
country: Japan
facility: Tominaga Hospital
city: Shibuya-ku
country: Japan
facility: Tokyo headache clinic
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
city: Taito City
country: Japan
facility: Eiju General Hospital
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Toyota-shi
country: Japan
facility: Toyota Memorial Hospital
city: Goyang-si
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
state: Gyeonggido
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Lublin
country: Poland
facility: ETG Lublin - PPDS
state: Lubelskie
city: Zamosc
country: Poland
facility: ETG Zamosc - PPDS
state: Lubelskie
city: Oswiecim
country: Poland
facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.
state: Malopolskie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by PRATIA - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: ETG Neuroscience - PPDS
state: Mazowieckie
city: Gdynia
country: Poland
facility: Centrum Medyczne Gdynia - PRATIA - PPDS
state: Pomorskie
city: Katowice
country: Poland
facility: Centrum Medyczne Silmedic Sp z o o
state: Slaskie
city: Poznan
country: Poland
facility: Solumed Centrum Medyczne
state: Wielkopolskie
city: Katowice
country: Poland
facility: Centrum Medyczne Katowice - PRATIA - PPDS
city: Sosnowiec
country: Poland
facility: Centrum Medyczne Kiepury Clinic
city: Wrocław
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
city: Banská Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
city: Bardejov
country: Slovakia
facility: IN MEDIC, s.r.o.
city: Dubnica nad Váhom
country: Slovakia
facility: KONZILIUM s.r.o
city: Prešov
country: Slovakia
facility: SANERA, s.r.o.
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro - CIOCC
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital, Linkou
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: