Eptinezumab in Adults With Migraine and Medication Overuse Headache
- Conditions
- MigraineMedication Overuse Headache
- Interventions
- Drug: Placebo
- Registration Number
- NCT04772742
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Double-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion Eptinezumab Eptinezumab Double-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion Placebo Eptinezumab Double-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion
- Primary Outcome Measures
Name Time Method Change from baseline in the number of monthly migraine days (MMDs) Weeks 1-12
- Secondary Outcome Measures
Name Time Method Change from baseline in rate of headaches with severe pain intensity Weeks 1-12 Patient Global Impression of Change (PGIC) score At Week 12 Response: ≥50% reduction from baseline in MMDs Weeks 1-12 Change from baseline in MMDs with use of acute medication Weeks 1-12 Change from baseline in the number of monthly headache days (MHDs) Weeks 1-12 Response: ≥75% reduction from baseline in MHDs Weeks 1-4 Change from baseline in the number of MHDs with use of acute medication Weeks 1-12 Change from baseline in rate of migraines with severe pain intensity Weeks 1-12 Most Bothersome Symptom (MBS) (score as measured relative to Screening) At Week 12 Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score Baseline to Week 12 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 Migraine rate on the day after dosing At Day 1 Response: ≥75% reduction from baseline in MMDs Weeks 1-12 Health Care Resources Utilization (HCRU) Baseline to Week 12 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.
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 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
Trial Locations
- Locations (40)
Taipei Veterans General Hospital
🇨🇳Taipei City, Taiwan
General Hospital of Northern Theater Command
🇨🇳Shenyang, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
🇨🇳Beijing, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, China
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Nowon Eulji Medical Center, Eulji University
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Beijing Chaoyang Hospital Capital Medical University
🇨🇳Beijing, China
Beijing Anzhen Hospital, Capital Medical University
🇨🇳Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The First Hospital of Jilin University
🇨🇳Changchun, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
The Second Hospital of Jilin University
🇨🇳Changchun, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
Mianyang Central Hospital
🇨🇳Mianyang, China
Jiangxi Pingxiang People's Hospital
🇨🇳Pingxiang, China
People's Hospital of Rizhao
🇨🇳Rizhao, China
The University of Hong Kong - Shenzhen Hospital
🇨🇳Shenzhen, China
Shanxi Provincial People Hospital
🇨🇳Taiyuan, China
People's Hospital of Zhengzhou
🇨🇳Zhengzhou, China
The 2nd Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, China
Pineo Medical Ecosystem
🇬🇪Tbilisi, Georgia
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Severance Hospital Yonsei University Health System - PPDS
🇰🇷Seoul, Korea, Republic of
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, China
Aversi Clinic LTD
🇬🇪Tbilisi, Georgia
Samsung Medical Center - PPDS
🇰🇷Seoul, Korea, Republic of
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan City, Taiwan
Peking University First Hospital
🇨🇳Beijing, China