Clinical trial NCT04688775: Eptinezumab in Participants With Episodic Cluster Headache
Official title: Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cluster Headache, Episodic
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period and Active Treatment Period of the study.

The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria

* 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).

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
Secondary outcomes:
measure: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
timeFrame: Baseline (Week 0), Days 1-3
measure: Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Time From First Infusion of IMP to Resolution of Cluster Headache Bout Within the First 4 Weeks
timeFrame: From first infusion (Baseline, Day 0) to 4 weeks
measure: Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
timeFrame: From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period
measure: Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
timeFrame: Baseline (Week 0), Days 1-3
measure: Change From Baseline to Week 1 in the Number of Weekly Attacks
timeFrame: Baseline (Week 0), Week 1
measure: Change From Baseline to Week 2 in the Number of Weekly Attacks
timeFrame: Baseline (Week 0), Week 2
measure: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1
timeFrame: Baseline (Week 0), Week 1
measure: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1
timeFrame: Baseline (Week 0), Week 1
measure: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain
timeFrame: Baseline (Week 0), Week 1
measure: Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
timeFrame: Baseline (Week 0), Week 2
measure: Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
timeFrame: Baseline (Week 0), Weeks 1-4
measure: Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4
timeFrame: Baseline (Week 0), Weeks 1-4
measure: Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Attack Over a Week) for Weeks 1, 2, 3, and 4
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, and 4
measure: Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4
timeFrame: Baseline (Week 0), Weeks 3-4
measure: Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
timeFrame: Weeks 1, 2, and 4
measure: Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
timeFrame: Baseline (Week 0), Weeks 2 and 4
measure: Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
timeFrame: Baseline (Week 0), Weeks 2 and 4
measure: Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner
timeFrame: Week 4
measure: HCRU Score: Number of Visits to a Specialist
timeFrame: Week 4
measure: HCRU Score: Number of Emergency Department Visits Due to Cluster Headache
timeFrame: Week 4
measure: HCRU Score: Number of Hospital Admissions Due to Cluster Headache
timeFrame: Week 4
measure: HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache
timeFrame: Week 4
measure: Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4
timeFrame: Baseline (Week 0), Week 4
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix Campus
state: Arizona
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Los Angeles
country: United States
facility: Clinical Research Institute
state: California
city: Palo Alto
country: United States
facility: Stanford Neurosciences Health Center
state: California
city: Denver
country: United States
facility: Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache
state: Connecticut
city: Tampa
country: United States
facility: Accel Research Sites - Tampa
state: Florida
city: Chicago
country: United States
facility: Diamond Headache Clinic
state: Illinois
city: Ann Arbor
country: United States
facility: Michigan Headache and Neurological Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Ridgeland
country: United States
facility: The Headache Center Mississippi
state: Mississippi
city: Springfield
country: United States
facility: Clinvest Research
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic - Neurological Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital - Center City Campus
state: Pennsylvania
city: Houston
country: United States
facility: Mischer Neuroscience Institute
state: Texas
city: Milwaukee
country: United States
facility: Froedtert and Medical College of Wisconsin
state: Wisconsin
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Bruxelles-Capitale
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
state: West-Vlaanderen
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien - Clinique MontLégia
city: Ostrava
country: Czechia
facility: Mestska Nemocnice Ostrava
state: Moravian-Silesian
city: Praha 4
country: Czechia
facility: Fakultní Thomayerova nemocnice
state: Prague
city: Praha 6
country: Czechia
facility: FORBELI s.r.o. Neurologicka Ambulance
state: Prague
city: Praha 8
country: Czechia
facility: Institut Neuropsychiatrické Péce
state: Prague
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
state: Hovedstaden
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
state: Midtjylland
city: Viborg
country: Denmark
facility: Hospitalsenhed Midt og Regionshospitalet Viborg
state: Midtjylland
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus - Esbjerg
city: Tallinn
country: Estonia
facility: Confido Meditsiinikeskus
state: Harjumaa
city: Kohtla-Järve
country: Estonia
facility: Ida-Viru Keskhaigla
state: Ida-Virumaa
city: Tartu
country: Estonia
facility: Tartu Ülikooli Kliinikum
state: Tartumaa
city: Tampere
country: Finland
facility: Tampereen Yliopistollinen Sairaala (TAYS)
state: Länsi-Suomen Lääni
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
state: Southern Finland
city: Turku
country: Finland
facility: Terveystalo Turku Pulssi
state: Western Finland
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Clermont-Ferrand Cedex 1
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
state: Auvergne-Rhône-Alpes
city: Nice Cedex 1
country: France
facility: Hôpital Cimiez
state: Côte-d'Or
city: Lille
country: France
facility: Hôpital Roger Salengro
state: Nord
city: Marseille Cedex 5
country: France
facility: Hôpital de la Timone
state: Provence Alpes Cote d'Azur
city: Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois
state: Rhone-Alpes
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne
state: Rhône
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Paris
country: France
facility: Hôpital Lariboisière
state: Île-de-France
city: Tbilisi
country: Georgia
facility: Pineo Medical Ecosystem
city: Tbilisi
country: Georgia
facility: Archangel Saint Michael Multiprofile Clinical Hospital
city: Tbilisi
country: Georgia
facility: Aversi Clinic - Central Branch
city: Tbilisi
country: Georgia
facility: Simon Khechinashvili University Hospital
city: Tbilisi
country: Georgia
facility: Consilium Medulla Multiprofile Clinic
city: Heidelberg
country: Germany
facility: Universität Heidelberg
state: Baden-Württemberg
city: München
country: Germany
facility: LMU Klinikum - Campus Grosshadern
state: Bayern
city: Frankfurt/ Main
country: Germany
facility: Kopfschmerzzentrum Frankfurt
state: Hessen
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock
state: Mecklenburg-Western-Pommerania
city: Bochum
country: Germany
facility: Neurologische Praxis Dr. Stude
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Kiel
country: Germany
facility: Schmerzklinik Kiel
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Athens
country: Greece
facility: Eginition University - General Hospital of Athens
state: Attica
city: Athina
country: Greece
facility: 401 General Military Hospital of Athens
state: Attica
city: Glyfada
country: Greece
facility: Mediterraneo Hospital
state: Attica
city: Larissa
country: Greece
facility: University General Hospital of Larissa
state: Thessaly
city: Patra
country: Greece
facility: General Hospital of Patras Agios Andreas
state: Western Greece
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic - Thessaloniki
city: Firenze
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
state: Florence
city: Rome
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
state: Roma
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
city: Bologna
country: Italy
facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna
city: Milano
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
city: Modena
country: Italy
facility: Azienda Ospedaliero - Universitaria di Modena
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
city: Pavia
country: Italy
facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
city: Rome
country: Italy
facility: Universita Campus Bio-Medico di Roma
city: Turin
country: Italy
facility: Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
city: Sendai-shi
country: Japan
facility: Sendai Headache And Neurology Clinic
state: Miyagi
city: Saitama-shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
state: Shizuoka
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum Sittard-Geleen
state: Limburg
city: Amsterdam
country: Netherlands
facility: Brain Research Center - Amsterdam
state: Noord-Holland
city: Oslo
country: Norway
facility: Oslo Hodepinesenter
city: Trondheim
country: Norway
facility: St. Olavs Hospital - Universitetssykehuset I Trondheim
city: Amadora
country: Portugal
facility: Hospital Prof. Doutor Fernando Fonseca
state: Lisboa
city: Lisbon
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria
state: Lisboa
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
state: Setúbal
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Nizhnij Novgorod
country: Russian Federation
facility: City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod
state: Nizhegorodskaya Oblast
city: Perm
country: Russian Federation
facility: Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...
state: Permsky
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Tartarstan
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University named after I.M. Sechenov
city: Moscow
country: Russian Federation
facility: University Headache Clinic
city: Novosibirsk
country: Russian Federation
facility: LLC Scientific and Practical Medical Center Innovation and Health
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
state: Madrid
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: València
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Halmstad
country: Sweden
facility: Hallands sjukhus Halmstad
state: Hallands Län
city: Lund
country: Sweden
facility: Skåneuro Privatmottagning
state: Skåne Län
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
state: Stockholms Län
city: Stockholm
country: Sweden
facility: Danderyds Sjukhus
state: Stockholms Län
city: Karlstad
country: Sweden
facility: Centralsjukhuset Karlstad
state: Värmlands Län
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: England
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: England
city: Newcastle-upon-Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust
state: England
city: Salford
country: United Kingdom
facility: Northern Care Alliance NHS Foundation Trust
state: England
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: