Eptinezumab in Adults With Migraine and Medication Overuse Headache

NCT ID: NCT04772742

Last Updated: 2022-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2022-09-30

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.

Conditions

Migraine; Medication Overuse Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

Eptinezumab - 100 mg, solution for infusion

Placebo

Double-Blind Treatment Phase (at baseline): Placebo by IV infusion

Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - solution for infusion

Eptinezumab

Intervention Type: DRUG

Eptinezumab - 100 mg, solution for infusion

Interventions

Placebo

Placebo - solution for infusion

Intervention Type: DRUG

Eptinezumab

Eptinezumab - 100 mg, solution for infusion

Intervention Type: DRUG

Other Intervention Names

Lu AG09221

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Beijing Chaoyang Hospital Capital Medical University

Beijing, , China

Beijing Anzhen Hospital, Capital Medical University

Beijing, , China

Peking University First Hospital

Beijing, , China

Xuanwu Hospital Capital Medical University

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Chinese PLA General Hospital

Beijing, , China

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing 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 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

Shengjing Hospital of China Medical University

Shenyang, , China

General Hospital of Northern Theater Command

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

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Renmin Hospital of Wuhan University

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, , China

Pineo Medical Ecosystem

Tbilisi, , Georgia

Aversi Clinic LTD

Tbilisi, , Georgia

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Severance Hospital Yonsei University Health System - PPDS

Seoul, , South Korea

Samsung Medical Center - PPDS

Seoul, , South Korea

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , Spain

Hospital Universitario La Paz - PPDS

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, , Spain

Taipei Veterans General Hospital

Taipei, , Taiwan

Tri-Service General Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan, , Taiwan

Countries

China; Georgia; South Korea; Spain; Taiwan

References

Yu S, Zhou J, Luo G, Xiao Z, Ettrup A, Jansson G, Florea I, Ranc K, Pozo-Rosich P. Efficacy and safety of eptinezumab in patients with chronic migraine and medication-overuse headache: a randomized, double-blind, placebo-controlled study. BMC Neurol. 2023 Dec 15;23(1):441. doi: 10.1186/s12883-023-03477-z.

Reference Type: DERIVED

PMID: 38102535 (View on PubMed)

Other Identifiers

19139A

Identifier Type: -

Identifier Source: org_study_id