Back to resultsEptinezumab in Adults With Migraine and Medication Overuse Headache (Sunlight)
Primary Purpose
Migraine, Medication Overuse Headache
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Eptinezumab
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
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
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical University
- Beijing Chaoyang Hospital Capital Medical University
- Beijing Anzhen Hospital, Capital Medical University
- Peking University First Hospital
- Xuanwu Hospital Capital Medical University
- Peking Union Medical College Hospital
- Chinese PLA General Hospital
- Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
- The First Hospital of Jilin University
- The Second Hospital of Jilin University
- The First Affiliated Hospital of Chongqing Medical University
- The Affiliated Hospital of Guizhou Medical University
- Mianyang Central Hospital
- Jiangxi Pingxiang People's Hospital
- People's Hospital of Rizhao
- Shengjing Hospital of China Medical University
- General Hospital of Northern Theater Command
- The University of Hong Kong - Shenzhen Hospital
- Shanxi Provincial People Hospital
- The 2nd Affiliated Hospital of Wenzhou Medical University
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Renmin Hospital of Wuhan University
- The First Affiliated Hospital of Xi'an Jiaotong University
- People's Hospital of Zhengzhou
- The First Affiliated Hospital of Zhengzhou University
- Affiliated Hospital of Jiangsu University
- Pineo Medical Ecosystem
- Aversi Clinic LTD
- Nowon Eulji Medical Center, Eulji University
- Severance Hospital Yonsei University Health System - PPDS
- Samsung Medical Center - PPDS
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario Vall d'Hebron - PPDS
- Hospital Universitario La Paz - PPDS
- Hospital Clinico Universitario de Valencia
- Hospital Universitari i Politecnic La Fe de Valencia
- Hospital Clinico Universitario Lozano Blesa
- Taipei Veterans General Hospital
- Tri-Service General Hospital
- Chang Gung Memorial Hospital, Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Eptinezumab
Placebo
Arm Description
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
Double-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion
Outcomes
Primary Outcome Measures
Change from baseline in the number of monthly migraine days (MMDs)
Secondary Outcome Measures
Change from baseline in MMDs with use of acute medication
Response: ≥50% reduction from baseline in MMDs
Migraine rate on the day after dosing
Response: ≥75% reduction from baseline in MMDs
Change from baseline in the number of monthly headache days (MHDs)
Response: ≥75% reduction from baseline in MMDs
Response: ≥75% reduction from baseline in MHDs
Response: ≥75% reduction from baseline in MHDs
Change from baseline in the number of MHDs with use of acute medication
Change from baseline in rate of migraines with severe pain intensity
Change from baseline in rate of headaches with severe pain intensity
Patient Global Impression of Change (PGIC) score
Most Bothersome Symptom (MBS) (score as measured relative to Screening)
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score
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)
Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04772742
Brief Title
Eptinezumab in Adults With Migraine and Medication Overuse Headache
Acronym
Sunlight
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Medication Overuse Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
193 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eptinezumab
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Double-Blind Treatment Phase (at baseline): Placebo by IV infusion
Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo - solution for infusion
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Other Intervention Name(s)
Lu AG09221
Intervention Description
Eptinezumab - 100 mg, solution for infusion
Primary Outcome Measure Information:
Title
Change from baseline in the number of monthly migraine days (MMDs)
Time Frame
Weeks 1-12
Secondary Outcome Measure Information:
Title
Change from baseline in MMDs with use of acute medication
Time Frame
Weeks 1-12
Title
Response: ≥50% reduction from baseline in MMDs
Time Frame
Weeks 1-12
Title
Migraine rate on the day after dosing
Time Frame
At Day 1
Title
Response: ≥75% reduction from baseline in MMDs
Time Frame
Weeks 1-4
Title
Change from baseline in the number of monthly headache days (MHDs)
Time Frame
Weeks 1-12
Title
Response: ≥75% reduction from baseline in MMDs
Time Frame
Weeks 1-12
Title
Response: ≥75% reduction from baseline in MHDs
Time Frame
Weeks 1-12
Title
Response: ≥75% reduction from baseline in MHDs
Time Frame
Weeks 1-4
Title
Change from baseline in the number of MHDs with use of acute medication
Time Frame
Weeks 1-12
Title
Change from baseline in rate of migraines with severe pain intensity
Time Frame
Weeks 1-12
Title
Change from baseline in rate of headaches with severe pain intensity
Time Frame
Weeks 1-12
Title
Patient Global Impression of Change (PGIC) score
Time Frame
At Week 12
Title
Most Bothersome Symptom (MBS) (score as measured relative to Screening)
Time Frame
At Week 12
Title
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score
Time Frame
Baseline to Week 12
Title
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)
Time Frame
Baseline to Week 12
Title
Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
Time Frame
Baseline to Week 12
Title
Health Care Resources Utilization (HCRU)
Description
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.
Time Frame
Baseline to Week 12
Title
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)
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Beijing Chaoyang Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
City
Beijing
ZIP/Postal Code
610041
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130022
Country
China
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
ZIP/Postal Code
550000
Country
China
Facility Name
Mianyang Central Hospital
City
Mianyang
ZIP/Postal Code
621000
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Facility Name
People's Hospital of Rizhao
City
Rizhao
ZIP/Postal Code
276826
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110004
Country
China
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110015
Country
China
Facility Name
The University of Hong Kong - Shenzhen Hospital
City
Shenzhen
ZIP/Postal Code
518053
Country
China
Facility Name
Shanxi Provincial People Hospital
City
Taiyuan
ZIP/Postal Code
030012
Country
China
Facility Name
The 2nd Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325035
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Facility Name
People's Hospital of Zhengzhou
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
ZIP/Postal Code
212001
Country
China
Facility Name
Pineo Medical Ecosystem
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Aversi Clinic LTD
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
ZIP/Postal Code
01830
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System - PPDS
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center - PPDS
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron - PPDS
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Universitario La Paz - PPDS
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Taoyuan City
ZIP/Postal Code
33305
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Eptinezumab in Adults With Migraine and Medication Overuse Headache
We'll reach out to this number within 24 hrs