Clinical trial NCT04772742: Eptinezumab in Adults With Migraine and Medication Overuse Headache
Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Medication Overuse Headache
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 193
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 and headache in patients with the combined diagnosis of migraine and medication overuse headache

Detailed description: Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91 patients in the placebo group.

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 Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). Patient will receive investigational medicinal product (IMP) at the Baseline Visit with either eptinezumab or placebo by IV infusion and at week 12 visit.

Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 guidelines confirmed at the Screening Visit with a history of migraine onset of at least 12 months prior to the Screening Visit.
* The patient has ≥8 migraine days per month for each month on average within the past 3 months prior to the Screening Visit.
* The patient has a diagnosis of medication overuse headache (MOH) as defined by IHS ICHD-3 guidelines.
* The patient has headache on ≥15 days/month for each month within the past 3 months prior to the Screening Visit.
* The patient has regular overuse of one or more drugs that can be taken for acute and/or symptomatic treatment of headache, for \>3 months.
* The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the Screening Period, based on prospectively collected information in the eDiary.
* The patient overuses drugs that can be taken for acute and/or symptomatic treatment of headache during the Screening Period, based on prospectively collected information in the eDiary.
* The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days of the Screening Period.
* The patient has had an onset of migraine at \<50 years of age

Exclusion Criteria:

* The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
* The patient has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
* The patient has a diagnosis of acute or active temporomandibular disorder.
* The patient 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), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
* Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients 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 patient 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 in- and exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in the number of monthly migraine days (MMDs)
timeFrame: Weeks 1-12
Secondary outcomes:
measure: Change from baseline in MMDs with use of acute medication
timeFrame: Weeks 1-12
measure: Response: ≥50% reduction from baseline in MMDs
timeFrame: Weeks 1-12
measure: Migraine rate on the day after dosing
timeFrame: At Day 1
measure: Response: ≥75% reduction from baseline in MMDs
timeFrame: Weeks 1-4
measure: Change from baseline in the number of monthly headache days (MHDs)
timeFrame: Weeks 1-12
measure: Response: ≥75% reduction from baseline in MMDs
timeFrame: Weeks 1-12
measure: Response: ≥75% reduction from baseline in MHDs
timeFrame: Weeks 1-12
measure: Response: ≥75% reduction from baseline in MHDs
timeFrame: Weeks 1-4
measure: Change from baseline in the number of MHDs with use of acute medication
timeFrame: Weeks 1-12
measure: Change from baseline in rate of migraines with severe pain intensity
timeFrame: Weeks 1-12
measure: Change from baseline in rate of headaches with severe pain intensity
timeFrame: Weeks 1-12
measure: Patient Global Impression of Change (PGIC) score
timeFrame: At Week 12
measure: Most Bothersome Symptom (MBS) (score as measured relative to Screening)
timeFrame: At 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: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Capital Medical University
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changchun
country: China
facility: The Second Hospital of Jilin University
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: Mianyang
country: China
facility: Mianyang Central Hospital
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
city: Rizhao
country: China
facility: People's Hospital of Rizhao
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
city: Shenzhen
country: China
facility: The University of Hong Kong - Shenzhen Hospital
city: Taiyuan
country: China
facility: Shanxi Provincial People Hospital
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem
city: Tbilisi
country: Georgia
facility: Aversi Clinic LTD
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron - PPDS
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - 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: 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: