Eptinezumab in Adults With Migraine and Medication Overuse Headache

NCT04772742 | Completed Phase 3 DMC

• 1 other identifier: 19139A
• Study Type: interventional
• Target: 193
• Locations: 5 countries
• Sites: 40

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

Conditions

Migraine; Medication Overuse Headache

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the number of monthly migraine days (MMDs)

  Weeks 1-12

Secondary Outcomes (18)

• Change from baseline in MMDs with use of acute medication

  Weeks 1-12

• Response: ≥50% reduction from baseline in MMDs

  Weeks 1-12

• Migraine rate on the day after dosing

  At Day 1

• Response: ≥75% reduction from baseline in MMDs

  Weeks 1-4

• Change from baseline in the number of monthly headache days (MHDs)

  Weeks 1-12

Study Arms (2)

Eptinezumab

EXPERIMENTAL

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

Drug: Eptinezumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Eptinezumab

Interventions

Placebo DRUG

Placebo - solution for infusion

Placebo

Eptinezumab DRUG

Eptinezumab - 100 mg, solution for infusion

Also known as: Lu AG09221

Eptinezumab; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (40)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Beijing Chaoyang Hospital Capital Medical University

Beijing, 100020, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Chinese PLA General Hospital

Beijing, 100853, China

Location

Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Beijing, 610041, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

The Second Hospital of Jilin University

Changchun, 130022, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, 550000, China

Location

Mianyang Central Hospital

Mianyang, 621000, China

Location

Jiangxi Pingxiang People's Hospital

Pingxiang, 337055, China

Location

People's Hospital of Rizhao

Rizhao, 276826, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110004, China

Location

General Hospital of Northern Theater Command

Shenyang, 110015, China

Location

The University of Hong Kong - Shenzhen Hospital

Shenzhen, 518053, China

Location

Shanxi Provincial People Hospital

Taiyuan, 030012, China

Location

The 2nd Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710061, China

Location

People's Hospital of Zhengzhou

Zhengzhou, 450003, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450052, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, 212001, China

Location

Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

Location

Aversi Clinic LTD

Tbilisi, 0160, Georgia

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Severance Hospital Yonsei University Health System - PPDS

Seoul, 03722, South Korea

Location

Samsung Medical Center - PPDS

Seoul, 06351, South Korea

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 8035, Spain

Location

Hospital Universitario La Paz - PPDS

Madrid, 28046, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38102535 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Headache Disorders, Secondary

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: February 17, 2021
• Primary Completion: May 23, 2022
• Study Completion: September 30, 2022
• Last Updated: October 31, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

GE (2); KR (3); TW (3); CN (26); ES (6)