Eptinezumab in Adults With Migraine and Medication Overuse Headache

Migraine Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772742
• Other study ID #: 19139A
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: September 30, 2022
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache
• Migraine
• Migraine Disorders

Intervention

Drug:
• Placebo
Placebo - solution for infusion
• Eptinezumab
Eptinezumab - 100 mg, solution for infusion

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing
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	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	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	Mianyang Central Hospital	Mianyang
China	Jiangxi Pingxiang People's Hospital	Pingxiang
China	People's Hospital of Rizhao	Rizhao
China	General Hospital of Northern Theater Command	Shenyang
China	Shengjing Hospital of China Medical University	Shenyang
China	The University of Hong Kong - Shenzhen Hospital	Shenzhen
China	Shanxi Provincial People Hospital	Taiyuan
China	The 2nd Affiliated Hospital of Wenzhou Medical University	Wenzhou
China	Renmin Hospital of Wuhan University	Wuhan
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
China	Affiliated Hospital of Jiangsu University	Zhenjiang
Georgia	Aversi Clinic LTD	Tbilisi
Georgia	Pineo Medical Ecosystem	Tbilisi
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Samsung Medical Center - PPDS	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System - PPDS	Seoul
Spain	Hospital Universitario Vall d'Hebron - PPDS	Barcelona
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
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,  Korea, Republic of,  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
Secondary	Change from baseline in MMDs with use of acute medication		Weeks 1-12
Secondary	Response: =50% reduction from baseline in MMDs		Weeks 1-12
Secondary	Migraine rate on the day after dosing		At Day 1
Secondary	Response: =75% reduction from baseline in MMDs		Weeks 1-4
Secondary	Change from baseline in the number of monthly headache days (MHDs)		Weeks 1-12
Secondary	Response: =75% reduction from baseline in MMDs		Weeks 1-12
Secondary	Response: =75% reduction from baseline in MHDs		Weeks 1-12
Secondary	Response: =75% reduction from baseline in MHDs		Weeks 1-4
Secondary	Change from baseline in the number of MHDs with use of acute medication		Weeks 1-12
Secondary	Change from baseline in rate of migraines with severe pain intensity		Weeks 1-12
Secondary	Change from baseline in rate of headaches with severe pain intensity		Weeks 1-12
Secondary	Patient Global Impression of Change (PGIC) score		At Week 12
Secondary	Most Bothersome Symptom (MBS) (score as measured relative to Screening)		At 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