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

NCT04418765 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 18898A
• Study Type: interventional
• Target: 892
• Locations: 17 countries
• Sites: 138

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12

  A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.

  Baseline, Weeks 1 - 12

Secondary Outcomes (40)

• Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

  Baseline to Weeks 1 - 12

• Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24

  Baseline, Weeks 13 - 24

• Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12

  Baseline to Weeks 1 - 12

• Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12

  Baseline, Week 12

• Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24

  Baseline to Weeks 13 - 24

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Eptinezumab 100 mg

EXPERIMENTAL

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

Drug: Eptinezumab

Eptinezumab 300 mg

EXPERIMENTAL

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

Drug: Eptinezumab

Interventions

Eptinezumab DRUG

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

Eptinezumab 100 mg; Eptinezumab 300 mg

Placebo DRUG

concentrate for solution for infusion, intravenously

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 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.

You may not qualify if:

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (138)

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Sarkis Clinical Trials - Gainesville

Gainesville, Florida, 32607, United States

Location

Accel Research Sites - Maitland

Maitland, Florida, 32751, United States

Location

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, 48104-5131, United States

Location

Clinical Research Institute Inc. - Minneapolis

Minneapolis, Minnesota, 55402, United States

Location

Albuqerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

Integrative Clinical Trials

Brooklyn, New York, 11229, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

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

Dayton, Ohio, 45424, United States

Location

Lynn Health Science Institute - Oklahoma City

Oklahoma City, Oklahoma, 73112, United States

Location

Clinical Neuroscience Solutions - Memphis

Memphis, Tennessee, 38119, United States

Location

Northwest Clinical Research Center (NWCRC)

Bellevue, Washington, 98007, United States

Location

Northwest Neurological

Spokane, Washington, 99202, United States

Location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Limburg, 3500, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

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

Bruges, West-Vlaanderen, 8000, Belgium

Location

Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum

Sofia, Sofia-Grad, 1113, Bulgaria

Location

First Multiprofile Hospital for Active Treatment - Sofia

Sofia, Sofia-Grad, 1142, Bulgaria

Location

Multiprofile Hospital for Active Treatment Heart and Brain EAD

Pleven, 5804, Bulgaria

Location

Medical Center - Teodora EOOD

Rousse, 7012, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

Medical Center Medica Plus

Veliko Tarnovo, 5006, Bulgaria

Location

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

Hradec Králové, Hradec Kralové, 500 03, Czechia

Location

Vestra Clinics

Rychnov nad Kněžnou, Hradec Kralové, 516 01, Czechia

Location

CCR Brno

Brno, Jihormoravsky Kraj, 602 00, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava-Poruba-Poruba, Moravian-Silesian, 708 52, Czechia

Location

CCR Prague

Prague, Prague, 130 00, Czechia

Location

Fakultní Thomayerova nemocnice

Prague, Prague, 140 59, Czechia

Location

Neurologicka Ambulance - Forbeli

Prague, Prague, 160 00, Czechia

Location

Neuropsychiatrie S.R.O.

Prague, Prague, 160 00, Czechia

Location

Institut Neuropsychiatrické Péce

Prague, Prague, 186 00, Czechia

Location

CCR Ostrava

Ostrava, Severomoravsky Kraj, 702 00, Czechia

Location

Fakultní Nemocnice u sv. Anny v Brne

Brno, South Moravian, 656 91, Czechia

Location

Nemocnice Jihlava

Jihlava, 586 01, Czechia

Location

Neurosanatio s.r.o

Litomyšl, 57001, Czechia

Location

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

Slezská Ostrava, 710 00, Czechia

Location

NeuroMed Zlín s.r.o.

Zlín, 760 01, Czechia

Location

Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Odense Universitetshospital

Odense, Region Syddanmark, 5000, Denmark

Location

Sydvestjysk Sygehus - Esbjerg

Esbjerg, 6700, Denmark

Location

Tampereen Yliopistollinen Sairaala

Tampere, Länsi-Suomen Lääni, 33520, Finland

Location

Terveystalo Ruoholahti

Helsinki, Southern Finland, 00180, Finland

Location

Terveystalo Turku Pulssi

Turku, Western Finland, 20100, Finland

Location

Itä-Suomen Yliopisto - Kuopion Kampus

Kuopio, 70210, Finland

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

Hôpital Cimiez

Nice, Côte-d'Or, 91179 - 06003, France

Location

Hôpital Charles-Nicolle

Rouen, Haute-Normandie, 76000, France

Location

Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Centre Hosptitalier Universitaire d'Angers

Angers, Pays de la Loire Region, 49 933, France

Location

Assistance Publique Hôpitaux de Marseille

Marseille, Provence Alpes Cote D'Azure, 13 354, France

Location

Hôpital Pierre Wertheimer

Bron, Rhone-Alps, 69500, France

Location

Helsicore - Israeli-Georgian Medical Research Clinic

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

Location

LLC Todua Clinic

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

Location

Pineo Medical Ecosystem

Tbilisi, 0114, Georgia

Location

Archangel Saint Michael Multiprofile Clinical Hospital

Tbilisi, 0159, Georgia

Location

Aversi Clinic - Central Branch

Tbilisi, 0160, Georgia

Location

Mediclub Georgia Medical

Tbilisi, 0160, Georgia

Location

Jerarsi Clinic

Tbilisi, 0167, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Center

Tbilisi, 0172, Georgia

Location

Simon Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Consilium Medulla Multiprofile Clinic

Tbilisi, 0186, Georgia

Location

Neuroplus

Mannheim, Baden-Wurttemberg, 68163, Germany

Location

MVZ Dr. Roth & Kollegen GbR

Ostfildern, Baden-Wurttemberg, 73760, Germany

Location

NeuroConcept AG

Stuttgart, Baden-Wurttemberg, 70182, Germany

Location

Praxis Dr. Steinwachs

Nuremberg, Bavaria, 90402, Germany

Location

CTC North

Hamburg, Hamburg (Hansestadt), 20251, Germany

Location

Synexus - Prüfzentrum Frankfurt/Main

Frankfurt am Main, Hesse, 60313, Germany

Location

Migräne- und Kopfschmerzklinik Königstein

Königstein im Taunus, Hesse, 61462, Germany

Location

Studienzentrum Nord West

Westerstede, Lower Saxony, 26655, Germany

Location

Neurozentrum Bielefeld

Bielefeld, North Rhine-Westphalia, 33647, Germany

Location

Neurologische Praxis Dr. Stude

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Praxis Astrid Gendolla

Essen, North Rhine-Westphalia, 45133, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Synexus - Leipzig

Leipzig, Saxony, 04103, Germany

Location

Synexus Clinical Research - Berlin

Berlin, 12627, Germany

Location

Neuropraxis München Süd

Unterhaching, 82008, Germany

Location

Valeomed Diagnosztikai Kozpont

Esztergom, Komarom-Esztergom County, 2500, Hungary

Location

Pest Megyei Flor Ferenc Korhaz

Kistarcsa, Pest County, 2143, Hungary

Location

UNO Medical Trials Kft.

Budapest, 1152, Hungary

Location

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

Rome, Roma, 00163, Italy

Location

Universita Campus Bio-Medico di Roma

Roma, Rome, 00128, Italy

Location

Azienda Ospedaliera - Universitaria Sant' Andrea

Roma, Rome, 00189, Italy

Location

IRCCS Istituto Delle Scienze Neurologiche di Bologna

Bologna, 40139, Italy

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50139, Italy

Location

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, 27100, Italy

Location

Centrum Medyczne Solumed

Poznan, Greater Poland Voivodeship, 60-529, Poland

Location

Synexus - Poznan

Poznan, Greater Poland Voivodeship, 60-702, Poland

Location

Centrum Medyczne Pratia - Bydgoszcz

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Pratia MCM Krakow

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Specjalistyczne Gabinety Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 30-539, Poland

Location

Instytut Zdrowia dr Boczarska-Jedynak

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

Centrum Medyczne Oporow

Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

Location

Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Lublin, Lublin Voivodeship, 20-093, Poland

Location

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

Lublin, Lublin Voivodeship, 20-582, Poland

Location

Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz

Warsaw, Masovian Voivodeship, 00-773, Poland

Location

SOMED CR - Warsaw

Warsaw, Masovian Voivodeship, 01-737, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Synexus - Gdynia

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

Synexus - Czestochowa

Częstochowa, Silesian Voivodeship, 42-202, Poland

Location

Synexus - Katowice

Katowice, Silesian Voivodeship, 40-040, Poland

Location

Neuro-Care Katowice

Siemianowice Śląskie, Silesian Voivodeship, 41-100, Poland

Location

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

Location

Centrum Medyczne Pratia - Czestochowa

Częstochowa, 42-200, Poland

Location

SOMED CR - Lodz

Lodz, 90-368, Poland

Location

University Headache Clinic

Moscow, 121467, Russia

Location

Neurologicka ambulancia MUDr. Dupejova s.r.o.

Banská Bystrica, 97404, Slovakia

Location

In Medic

Bardejov, 8501, Slovakia

Location

MEDBAJ s.r.o.

Dolný Kubín, 026 01, Slovakia

Location

Medicínske Centrum Konzílium - Dubnica nad Vahom

Dubnica nad Váhom, 01841, Slovakia

Location

Hospital Universitario de Basurto

Bilbao, Biscay, 48013, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Clinica Universidad de Navarra - Pamplona

Pamplona, Navarre, 31008, Spain

Location

Hospital Alvaro Cunqueiro - Clinico Universitario Vigo

Vigo, Pontevedra, 36213, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Migränkliniken Europa AB

Värnamo, Kronoborgs Län, 331 50, Sweden

Location

Stortorgets neurologmottagning

Helsingborg, Skåne County, 25220, Sweden

Location

Centralsjukhuset Kristianstad

Kristianstad, Skåne County, 291 85, Sweden

Location

Universitetssjukhuset i Linköping

Linköping, Östergötland County, 581 85, Sweden

Location

Synexus - Scotland Clinical Research Centre

Bellshill, England, ML4 3NJ, United Kingdom

Location

Synexus - The Lancashire Clinic

Chorley, England, PR7 7NA, United Kingdom

Location

Synexus Midlands Clinical Research Centre

Edgbaston, England, B15 2SQ, United Kingdom

Location

Synexus - The Hexham Clinic

Hexham, England, NE46 1QJ, United Kingdom

Location

Synexus - Merseyside Clinical Research Centre

Liverpool, England, L22 0LG, United Kingdom

Location

Panthera Biopartners - North London

London, England, EN3 4GS, United Kingdom

Location

Synexus - Manchester Clinical Research Centre

Manchester, England, M15 6SE, United Kingdom

Location

Panthera Biopartners - Manchester

Manchester, England, OL11 4AU, United Kingdom

Location

Panthera Biopartners - Preston

Preston, England, PR2 9QB, United Kingdom

Location

Synexus - Thames Valley Clinical Research Centre

Reading, England, RG2 0TG, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Salford, England, M6 8HD, United Kingdom

Location

Synexus - Wales

Cardiff, Wales, CF15 9SS, United Kingdom

Location

Related Publications (10)

• Tassorelli C, Starling AJ, Awad SF, Lee XY, Boserup LP, Asher D, Soni-Brahmbhatt S, Sperling B, Goadsby PJ. Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial. Eur J Neurol. 2025 Dec;32(12):e70460. doi: 10.1111/ene.70460.

  PMID: 41395928 DERIVED

• 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.

  PMID: 39692817 DERIVED

• 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.

  PMID: 38549121 DERIVED

• 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.

  PMID: 38236314 DERIVED

• Ashina M, Tepper SJ, Gendolla A, Sperling B, Ettrup A, Josiassen MK, Starling AJ. Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial. J Headache Pain. 2023 Nov 20;24(1):155. doi: 10.1186/s10194-023-01688-w.

  PMID: 37985968 DERIVED

• 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.

  PMID: 37256558 DERIVED

• 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.

  PMID: 37125484 DERIVED

• 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.

  PMID: 36583633 DERIVED

• 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.

  PMID: 36460983 DERIVED

• 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.

  PMID: 35716692 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 3, 2020
• First Posted: June 5, 2020
• Study Start: June 1, 2020
• Primary Completion: July 15, 2021
• Study Completion: September 15, 2022
• Last Updated: September 29, 2023
• Results First Posted: July 22, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

IT (6); BE (4); ES (11); CZ (15); SL (4); DK (3); FI (5); SE (4); US (14); GB (12); PL (19); DE (15); HU (3); GE (10); RU (1); FR (6); BU (6)