Eptinezumab in Participants With Episodic Cluster Headache

NCT04688775 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 19386A
• Study Type: interventional
• Target: 231
• Locations: 18 countries
• Sites: 109

Brief Summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Conditions

Cluster Headache, Episodic

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2

  The participant completed a CH eDiary, daily, and recorded for each day/week whether he/she had any CH attacks. For each CH attack, the start date and time was collected. The participant recorded further daily information regarding CH characteristics and intake of acute medication for CH. CH items were assessed with a yes/no response.

  Baseline (Week 0), Weeks 1-2

Secondary Outcomes (28)

• Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2

  Baseline (Week 0), Weeks 1-2

• Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2

  Baseline (Week 0), Weeks 1-2

• Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3

  Baseline (Week 0), Days 1-3

• Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2

  Baseline (Week 0), Weeks 1-2

• Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks

  From first infusion (Baseline, Day 0) to 4 weeks

Study Arms (2)

Sequence 1: Eptinezumab Then Placebo

EXPERIMENTAL

Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period

Drug: Eptinezumab; Drug: Placebo

Sequence 2: Placebo Then Eptinezumab

EXPERIMENTAL

Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period

Drug: Eptinezumab; Drug: Placebo

Interventions

Eptinezumab DRUG

Eptinezumab - concentrate for solution for infusion, intravenously

Sequence 1: Eptinezumab Then Placebo; Sequence 2: Placebo Then Eptinezumab

Placebo DRUG

Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously

Sequence 1: Eptinezumab Then Placebo; Sequence 2: Placebo Then Eptinezumab

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 episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit 1.
• The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated.
• The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine).
• The participant is, at Screening Visit 2, in cluster headache bout, characterized by the presence of at least one typical cluster headache attack, that started not later than 1 week prior to Screening Visit 2.
• The participant has a medical history of first symptoms of cluster headache from ≤60 years of age.

You may not qualify if:

• The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP monoclonal antibodies \[mAbs\] and gepants).
• The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome).
• The participant has a history or diagnosis of hypnic headache, hemicrania continua, new daily persistent headache, chronic migraine 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).
• Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Participants 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 Visit 2 are also excluded.
• The participant is, at Screening Visit 2, at significant risk of suicide.
• The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (120)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic in Arizona - Phoenix Campus

Phoenix, Arizona, 85054, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

Clinical Research Institute

Los Angeles, California, 90048, United States

Location

Stanford Neurosciences Health Center

Palo Alto, California, 94304, United States

Location

Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center

Denver, Colorado, 80218, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510-2483, United States

Location

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

Accel Research Sites - Tampa

Tampa, Florida, 33634, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60642, United States

Location

Michigan Headache and Neurological Institute

Ann Arbor, Michigan, 48104-5131, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

The Headache Center Mississippi

Ridgeland, Mississippi, 39157, United States

Location

Clinvest Research

Springfield, Missouri, 65810, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Headache Wellness Center

Greensboro, North Carolina, 27405, United States

Location

Cleveland Clinic - Neurological Institute

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Hightower Clinical

Oklahoma City, Oklahoma, 73134, United States

Location

Thomas Jefferson University Hospital - Center City Campus

Philadelphia, Pennsylvania, 19107, United States

Location

Mischer Neuroscience Institute

Houston, Texas, 77030, United States

Location

Froedtert and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

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

Bruges, West-Vlaanderen, 8000, Belgium

Location

Centre Hospitalier Chretien - Clinique MontLégia

Liège, 4000, Belgium

Location

Mestska Nemocnice Ostrava

Ostrava, Moravian-Silesian, 728 80, Czechia

Location

Fakultní Thomayerova nemocnice

Prague, Prague, 140 59, Czechia

Location

FORBELI s.r.o. Neurologicka Ambulance

Prague, Prague, 160 00, Czechia

Location

Institut Neuropsychiatrické Péce

Prague, Prague, 186 00, Czechia

Location

Rigshospitalet Glostrup

Glostrup Municipality, Capital Region, 2600, Denmark

Location

Aarhus Universitetshospital

Aarhus N, Central Jutland, 8200, Denmark

Location

Hospitalsenhed Midt og Regionshospitalet Viborg

Viborg, Central Jutland, 8800, Denmark

Location

Sydvestjysk Sygehus - Esbjerg

Esbjerg, 6700, Denmark

Location

Confido Meditsiinikeskus

Tallinn, Harju, 10138, Estonia

Location

Ida-Viru Keskhaigla

Kohtla-Järve, Ida-Virumaa, 31025, Estonia

Location

Tartu Ülikooli Kliinikum

Tartu, Tartu, 50406, Estonia

Location

Tampereen Yliopistollinen Sairaala (TAYS)

Tampere, Länsi-Suomen Lääni, 33520, Finland

Location

Terveystalo Ruoholahti

Helsinki, Southern Finland, 00180, Finland

Location

Terveystalo Turku Pulssi

Turku, Western Finland, 20100, Finland

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003, France

Location

Centre Hospitalier Annecy Genevois

Metz-Tessy, Auvergne-Rhône-Alpes, 74370, France

Location

Hôpital Cimiez

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

Location

Hôpital Roger Salengro

Lille, Nord, 59037, France

Location

Hôpital de la Timone

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

Location

Centre Hospitalier Universitaire de Saint-Étienne

Saint-Priest-en-Jarez, Rhône, 42055, France

Location

Hôpital Pierre Wertheimer

Bron, France

Location

Hôpital Lariboisière

Paris, Île-de-France Region, 75010, France

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

Simon Khechinashvili University Hospital

Tbilisi, 0179, Georgia

Location

Consilium Medulla Multiprofile Clinic

Tbilisi, 0186, Georgia

Location

Universität Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

LMU Klinikum - Campus Grosshadern

München, Bavaria, D-81377, Germany

Location

Kopfschmerzzentrum Frankfurt

Frankfurt am Main, Hesse, 65929, Germany

Location

Universitätsmedizin Rostock

Rostock, Mecklenburg-Western-Pommerania, 18147, Germany

Location

Neurologische Praxis Dr. Stude

Bochum, North Rhine-Westphalia, 44787, Germany

Location

Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie

Essen, North Rhine-Westphalia, 45133, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitatsklinikum Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

Location

Schmerzklinik Kiel

Kiel, Schleswig-Holstein, 24149, Germany

Location

Charité Campus Mitte

Berlin, 10117, Germany

Location

401 General Military Hospital of Athens

Athens, Attica, 115 25, Greece

Location

Eginition University - General Hospital of Athens

Athens, Attica, 11528, Greece

Location

Mediterraneo Hospital

Glyfada, Attica, 16675, Greece

Location

University General Hospital of Larissa

Larissa, Thessaly, 41110, Greece

Location

General Hospital of Patras Agios Andreas

Pátrai, West Greece, 263 32, Greece

Location

Euromedica General Clinic - Thessaloniki

Thessaloniki, 54645, Greece

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, Florence, 50134, Italy

Location

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

Rome, Roma, 00163, Italy

Location

Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

Bari, 70124, Italy

Location

IRCCS Istituto Delle Scienze Neurologiche di Bologna

Bologna, 40123, Italy

Location

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...

Milan, 20133, Italy

Location

Azienda Ospedaliero - Universitaria di Modena

Modena, 41124, Italy

Location

Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

Napoli, 280138, Italy

Location

Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

Pavia, 27100, Italy

Location

Universita Campus Bio-Medico di Roma

Rome, 00128, Italy

Location

Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

Turin, 10126, Italy

Location

Sendai Headache And Neurology Clinic

Sendai, Miyagi, 982-0014, Japan

Location

Saitama Neuropsychiatric Institute

Saitama-shi, Saitama, 338-8577, Japan

Location

Japanese Red Cross Shizuoka Hospital

Shizuoka, Shizuoka, 420-0853, Japan

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, 6532 SZ, Netherlands

Location

Zuyderland Medisch Centrum Sittard-Geleen

Geleen, Limburg, 6162 BG, Netherlands

Location

Brain Research Center - Amsterdam

Amsterdam, North Holland, 1081 GN, Netherlands

Location

Oslo Hodepinesenter

Oslo, 0275, Norway

Location

St. Olavs Hospital - Universitetssykehuset I Trondheim

Trondheim, 7030, Norway

Location

Hospital Prof. Doutor Fernando Fonseca

Amadora, Lisbon District, 2720-276, Portugal

Location

Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

Location

Hospital Garcia de Orta

Almada, Setúbal District, 2805-267, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod

Nizhny Novgorod, Nizhny Novgorod Oblast, 603076, Russia

Location

Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...

Perm, Permsky, 614990, Russia

Location

Kazan State Medical University

Kazan', Tartarstan, 420012, Russia

Location

First Moscow State Medical University named after I.M. Sechenov

Moscow, 119146, Russia

Location

University Headache Clinic

Moscow, 121467, Russia

Location

LLC Scientific and Practical Medical Center Innovation and Health

Novosibirsk, 630054, Russia

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen Macarena

Castilleja de la Cuesta, Sevilla, 41950, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08017, 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 Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hallands sjukhus Halmstad

Halmstad, Halland County, 301 85, Sweden

Location

Skåneuro Privatmottagning

Lund, Skåne County, 222 22, Sweden

Location

Karolinska Universitetssjukhuset Huddinge

Huddinge, Stockholm County, 141 57, Sweden

Location

Danderyds Sjukhus

Stockholm, Stockholm County, 182 88, Sweden

Location

Centralsjukhuset Karlstad

Karlstad, Värmland County, 651 85, Sweden

Location

Hull University Teaching Hospitals NHS Trust

Hull, England, HU3 2JZ, United Kingdom

Location

The Walton Centre NHS Foundation Trust

Liverpool, England, L9 7LJ, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, England, SE5 9PJ, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Northern Care Alliance NHS Foundation Trust

Salford, England, M6 8HD, United Kingdom

Location

Related Publications (1)

• Jensen RH, Tassorelli C, Tepper SJ, Charles A, Goadsby PJ, Snoer AH, Sperling B, Krog Josiassen M, Borgen Linander C, Ettrup A, Boneva N. Efficacy and Safety of Eptinezumab in Episodic Cluster Headache: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):706-714. doi: 10.1001/jamaneurol.2025.1317.

  PMID: 40388178 DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

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

LundbeckClinicalTrials@Lundbeck.com

+45 36301311

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: December 24, 2020
• First Posted: December 30, 2020
• Study Start: December 23, 2020
• Primary Completion: June 14, 2023
• Study Completion: October 5, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Locations

ES (3); GE (5); DK (4); FI (4); IT (10); NO (2); SE (5); NL (3); GR (6); US (24); DE (10); JP (3); BE (3); FR (8); PT (4); GB (5); RU (6); CZ (4)