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MigrainePhase 3SunlightNCT04772742

Eptinezumab in Adults With Migraine and Medication Overuse Headache

A Phase 3 study testing Eptinezumab in people with Migraine and Medication Overuse Headache, run by H. Lundbeck A/S at 40 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine, Medication Overuse Headache
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
40 sitesin 5 countries
Study dates
17 Feb 2021to 30 Sep 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

40 sites in 5 countries.

40 sites in 5 countries

China26 sites

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing, 100020

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, 100029

  • Peking University First Hospital

    Beijing, 100034

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Chinese PLA General Hospital

    Beijing, 100853

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

    Beijing, 610041

  • The First Hospital of Jilin University

    Changchun, 130021

  • The Second Hospital of Jilin University

    Changchun, 130022

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, 550000

  • Mianyang Central Hospital

    Mianyang, 621000

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, 337055

  • People's Hospital of Rizhao

    Rizhao, 276826

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • General Hospital of Northern Theater Command

    Shenyang, 110015

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen, 518053

  • Shanxi Provincial People Hospital

    Taiyuan, 030012

  • The 2nd Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325035

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • People's Hospital of Zhengzhou

    Zhengzhou, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, 212001

Other trials in China

Spain6 sites

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

South Korea3 sites

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 03722

  • Samsung Medical Center - PPDS

    Seoul, 06351

Other trials in South Korea

Taiwan3 sites

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Tri-Service General Hospital

    Taipei, 11490

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan City, 33305

Other trials in Taiwan

Georgia2 sites

  • Pineo Medical Ecosystem

    Tbilisi, 0114

  • Aversi Clinic LTD

    Tbilisi, 0160

Other trials in Georgia

About this study

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

This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

Read the 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.

Being tested
Placebo, Eptinezumab
Medical subject headings
Migraine Disorders, Headache Disorders, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo - solution for infusion

  • EptinezumabDrug

    Also called Lu AG09221

    Eptinezumab - 100 mg, solution for infusion

Study groups in NCT04772742
Study groupRoleWhat they receive
EptinezumabExperimentalDouble-Blind Treatment Phase (at baseline): 100 mg eptinezumab by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion
Receives: Drug: Eptinezumab
PlaceboPlacebo comparatorDouble-Blind Treatment Phase (at baseline): Placebo by IV infusion Open-Label Treatment Phase (at week 12): 100 mg eptinezumab by IV infusion
Receives: Drug: Placebo; Drug: Eptinezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Weeks 1-12

Secondary outcomes (18)

  1. Change from baseline in MMDs with use of acute medication

    Measured: Weeks 1-12

  2. Response: ≥50% reduction from baseline in MMDs

    Measured: Weeks 1-12

  3. Migraine rate on the day after dosing

    Measured: At Day 1

  4. Response: ≥75% reduction from baseline in MMDs

    Measured: Weeks 1-4

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

    Measured: Weeks 1-12

  6. Response: ≥75% reduction from baseline in MMDs

    Measured: Weeks 1-12

  7. Response: ≥75% reduction from baseline in MHDs

    Measured: Weeks 1-12

  8. Response: ≥75% reduction from baseline in MHDs

    Measured: Weeks 1-4

  9. Change from baseline in the number of MHDs with use of acute medication

    Measured: Weeks 1-12

  10. Change from baseline in rate of migraines with severe pain intensity

    Measured: Weeks 1-12

  11. Change from baseline in rate of headaches with severe pain intensity

    Measured: Weeks 1-12

  12. Patient Global Impression of Change (PGIC) score

    Measured: At Week 12

  13. Most Bothersome Symptom (MBS) (score as measured relative to Screening)

    Measured: At Week 12

  14. Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score

    Measured: Baseline to Week 12

  15. 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)

    Measured: Baseline to Week 12

  16. Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score

    Measured: Baseline to Week 12

  17. 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.

    Measured: Baseline to Week 12

  18. 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)

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2021
  2. Study start17 Feb 2021
  3. Primary completion23 May 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04772742
Sponsor's protocol ID
19139A
Acronym
Sunlight
Status last verified
Oct 2022
First submitted
23 Feb 2021
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 38102535

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Migraine and Medication Overuse Headache, run by H. Lundbeck A/S at 40 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China, Spain, South Korea, Taiwan, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the number of monthly migraine days (MMDs) (time frame: Weeks 1-12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04772742, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.

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