A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

NCT ID: NCT04418765

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 892 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-09-15

Brief Summary

Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.

Detailed Description

The total study duration from the screening visit to the completion visit is approximately 76 weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24 weeks) and a treatment extension period (48 weeks).

The participant will start treatment at the baseline visit and follow a 12-week dosing schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV) infusion. Participants who were assigned to placebo in the placebo-controlled treatment period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or eptinezumab 100 mg.

Conditions

Migraine

Study Design

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

Study Groups

Placebo

Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

concentrate for solution for infusion, intravenously

Eptinezumab 100 mg

Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)

Eptinezumab 300 mg

Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)

Interventions

Eptinezumab

Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)

Intervention Type: DRUG

Placebo

concentrate for solution for infusion, intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
• The participant has a migraine onset of ≤50 years of age.
• The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit.
• The participant fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
• For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
• For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
• The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
• The participant has a history of either previous or active use of triptans for migraine.

Exclusion Criteria

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
• The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
• The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome).
• The participant has a diagnosis of acute or active temporomandibular disorder.
• The participant 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), ophthalmoplegic migraine, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
• The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
• The participant has a history of clinically significant cardiovascular disease or 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

Diablo Clinical Research

Walnut Creek, California, United States

Sarkis Clinical Trials - Gainesville

Gainesville, Florida, United States

Accel Research Sites - Maitland

Maitland, Florida, United States

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, United States

Clinical Research Institute Inc. - Minneapolis

Minneapolis, Minnesota, United States

Albuqerque Clinical Trials

Albuquerque, New Mexico, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Integrative Clinical Trials

Brooklyn, New York, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Hometown Urgent Care & Occupational Health/Hometown Research - Huber Heights

Dayton, Ohio, United States

Lynn Health Science Institute - Oklahoma City

Oklahoma City, Oklahoma, United States

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, United States

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington, United States

Northwest Neurological

Spokane, Washington, United States

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Limburg, Belgium

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

Bruges, West-Vlaanderen, Belgium

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, Sofia-Grad, Bulgaria

First Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, Bulgaria

Multiprofile Hospital for Active Treatment Heart and Brain EAD

Pleven, , Bulgaria

Medical Center - Teodora EOOD

Rousse, , Bulgaria

Acibadem City Clinic Tokuda Hospital

Sofia, , Bulgaria

Medical Center Medica Plus

Veliko Tarnovo, , Bulgaria

MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance

Hradec Králové, Hradec Kralové, Czechia

Vestra Clinics

Rychnov nad Kněžnou, Hradec Kralové, Czechia

CCR Brno

Brno, Jihormoravsky Kraj, Czechia

Fakultni nemocnice Ostrava

Ostrava-Poruba-Poruba, Moravian-Silesian, Czechia

CCR Prague

Prague, Prague, Czechia

Fakultní Thomayerova nemocnice

Prague, Prague, Czechia

Neurologicka Ambulance - Forbeli

Prague, Prague, Czechia

Neuropsychiatrie S.R.O.

Prague, Prague, Czechia

Institut Neuropsychiatrické Péce

Prague, Prague, Czechia

CCR Ostrava

Ostrava, Severomoravsky Kraj, Czechia

Fakultní Nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

Nemocnice Jihlava

Jihlava, , Czechia

Neurosanatio s.r.o

Litomyšl, , Czechia

Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon

Slezská Ostrava, , Czechia

NeuroMed Zlín s.r.o.

Zlín, , Czechia

Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, Denmark

Odense Universitetshospital

Odense, Region Syddanmark, Denmark

Sydvestjysk Sygehus - Esbjerg

Esbjerg, , Denmark

Tampereen Yliopistollinen Sairaala

Tampere, Länsi-Suomen Lääni, Finland

Terveystalo Ruoholahti

Helsinki, Southern Finland, Finland

Terveystalo Turku Pulssi

Turku, Western Finland, Finland

Itä-Suomen Yliopisto - Kuopion Kampus

Kuopio, , Finland

Terveystalo Tampere

Tampere, , Finland

Hôpital Cimiez

Nice, Côte-d'Or, France

Hôpital Charles-Nicolle

Rouen, Haute-Normandie, France

Hôpital Roger Salengro

Lille, Nord, France

Centre Hosptitalier Universitaire d'Angers

Angers, Pays de la Loire Region, France

Assistance Publique Hôpitaux de Marseille

Marseille, Provence Alpes Cote D'Azure, France

Hôpital Pierre Wertheimer

Bron, Rhone-Alps, France

Helsicore - Israeli-Georgian Medical Research Clinic

T'bilisi, K'alak'i T'bilisi, Georgia

LLC Todua Clinic

T'bilisi, K'alak'i T'bilisi, Georgia

Pineo Medical Ecosystem

Tbilisi, , Georgia

Archangel Saint Michael Multiprofile Clinical Hospital

Tbilisi, , Georgia

Aversi Clinic - Central Branch

Tbilisi, , Georgia

Mediclub Georgia Medical

Tbilisi, , Georgia

Jerarsi Clinic

Tbilisi, , Georgia

Malkhaz Katsiashvili Multiprofile Emergency Center

Tbilisi, , Georgia

Simon Khechinashvili University Hospital

Tbilisi, , Georgia

Consilium Medulla Multiprofile Clinic

Tbilisi, , Georgia

Neuroplus

Mannheim, Baden-Wurttemberg, Germany

MVZ Dr. Roth & Kollegen GbR

Ostfildern, Baden-Wurttemberg, Germany

NeuroConcept AG

Stuttgart, Baden-Wurttemberg, Germany

Praxis Dr. Steinwachs

Nuremberg, Bavaria, Germany

CTC North

Hamburg, Hamburg (Hansestadt), Germany

Synexus - Prüfzentrum Frankfurt/Main

Frankfurt am Main, Hesse, Germany

Migräne- und Kopfschmerzklinik Königstein

Königstein im Taunus, Hesse, Germany

Studienzentrum Nord West

Westerstede, Lower Saxony, Germany

Neurozentrum Bielefeld

Bielefeld, North Rhine-Westphalia, Germany

Neurologische Praxis Dr. Stude

Bochum, North Rhine-Westphalia, Germany

Praxis Astrid Gendolla

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Synexus - Leipzig

Leipzig, Saxony, Germany

Synexus Clinical Research - Berlin

Berlin, , Germany

Neuropraxis München Süd

Unterhaching, , Germany

Valeomed Diagnosztikai Kozpont

Esztergom, Komarom-Esztergom County, Hungary

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, Pest County, Hungary

UNO Medical Trials Kft.

Budapest, , Hungary

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Rome, Roma, Italy

Universita Campus Bio-Medico di Roma

Roma, Rome, Italy

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, Rome, Italy

IRCCS Istituto Delle Scienze Neurologiche di Bologna

Bologna, , Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, , Italy

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, , Italy

Centrum Medyczne Solumed

Poznan, Greater Poland Voivodeship, Poland

Synexus - Poznan

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Pratia - Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, Poland

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Lesser Poland Voivodeship, Poland

Instytut Zdrowia dr Boczarska-Jedynak

Oświęcim, Lesser Poland Voivodeship, Poland

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship, Poland

Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Lublin, Lublin Voivodeship, Poland

Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej

Lublin, Lublin Voivodeship, Poland

Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Warsaw, Masovian Voivodeship, Poland

SOMED CR - Warsaw

Warsaw, Masovian Voivodeship, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Masovian Voivodeship, Poland

Synexus - Gdynia

Gdynia, Pomeranian Voivodeship, Poland

Synexus - Czestochowa

Częstochowa, Silesian Voivodeship, Poland

Synexus - Katowice

Katowice, Silesian Voivodeship, Poland

Neuro-Care Katowice

Siemianowice Śląskie, Silesian Voivodeship, Poland

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, Warmian-Masurian Voivodeship, Poland

Centrum Medyczne Pratia - Czestochowa

Częstochowa, , Poland

SOMED CR - Lodz

Lodz, , Poland

University Headache Clinic

Moscow, , Russia

Neurologicka ambulancia MUDr. Dupejova s.r.o.

Banská Bystrica, , Slovakia

In Medic

Bardejov, , Slovakia

MEDBAJ s.r.o.

Dolný Kubín, , Slovakia

Medicínske Centrum Konzílium - Dubnica nad Vahom

Dubnica nad Váhom, , Slovakia

Hospital Universitario de Basurto

Bilbao, Biscay, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, Spain

Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

Vigo, Pontevedra, Spain

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Migränkliniken Europa AB

Värnamo, Kronoborgs Län, Sweden

Stortorgets neurologmottagning

Helsingborg, Skåne County, Sweden

Centralsjukhuset Kristianstad

Kristianstad, Skåne County, Sweden

Universitetssjukhuset i Linköping

Linköping, Östergötland County, Sweden

Synexus - Scotland Clinical Research Centre

Bellshill, England, United Kingdom

Synexus - The Lancashire Clinic

Chorley, England, United Kingdom

Synexus Midlands Clinical Research Centre

Edgbaston, England, United Kingdom

Synexus - The Hexham Clinic

Hexham, England, United Kingdom

Synexus - Merseyside Clinical Research Centre

Liverpool, England, United Kingdom

Panthera Biopartners - North London

London, England, United Kingdom

Synexus - Manchester Clinical Research Centre

Manchester, England, United Kingdom

Panthera Biopartners - Manchester

Manchester, England, United Kingdom

Panthera Biopartners - Preston

Preston, England, United Kingdom

Synexus - Thames Valley Clinical Research Centre

Reading, England, United Kingdom

Northern Care Alliance NHS Foundation Trust

Salford, England, United Kingdom

Synexus - Wales

Cardiff, Wales, United Kingdom

Countries

United States; Belgium; Bulgaria; Czechia; Denmark; Finland; France; Georgia; Germany; Hungary; Italy; Poland; Russia; Slovakia; Spain; Sweden; United Kingdom

References

Barbanti P, Awad SF, Rae-Espinoza H, Regnier SA, Lee XY, Goadsby PJ. Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: post hoc analysis of the DELIVER trial. J Patient Rep Outcomes. 2024 Dec 18;8(1):146. doi: 10.1186/s41687-024-00813-w.

Reference Type: DERIVED

PMID: 39692817 (View on PubMed)

Jonsson L, Awad SF, Regnier SA, Talon B, Kymes S, Lee XY, Goadsby PJ. Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab. J Headache Pain. 2024 Mar 28;25(1):45. doi: 10.1186/s10194-024-01752-z.

Reference Type: DERIVED

PMID: 38549121 (View on PubMed)

Pozo-Rosich P, Ashina M, Tepper SJ, Jensen S, Boserup LP, Josiassen MK, Sperling B. Eptinezumab Demonstrated Efficacy Regardless of Prior Preventive Migraine Treatment Failure Type: Post Hoc Analyses of the DELIVER Study. Neurol Ther. 2024 Apr;13(2):339-353. doi: 10.1007/s40120-023-00575-5. Epub 2024 Jan 18.

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Jonsson L, Regnier SA, Kymes S, Awad SF, Talon B, Lee XY, Goadsby PJ. Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial. Expert Rev Pharmacoecon Outcomes Res. 2023 Jul-Dec;23(7):797-803. doi: 10.1080/14737167.2023.2219898. Epub 2023 Jun 2.

Reference Type: DERIVED

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Ashina M, Lanteri-Minet M, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B, Pozo-Rosich P. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 May;43(5):3331024231170807. doi: 10.1177/03331024231170807.

Reference Type: DERIVED

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Goadsby PJ, Barbanti P, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. Eur J Neurol. 2023 Apr;30(4):1089-1098. doi: 10.1111/ene.15670. Epub 2023 Jan 21.

Reference Type: DERIVED

PMID: 36583633 (View on PubMed)

Barbanti P, Goadsby PJ, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study. J Headache Pain. 2022 Dec 2;23(1):153. doi: 10.1186/s10194-022-01521-w.

Reference Type: DERIVED

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Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

18898A

Identifier Type: -

Identifier Source: org_study_id