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Eptinezumab in Participants With Episodic Cluster Headache (ALLEVIATE)

Primary Purpose

Cluster Headache, Episodic

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Placebo
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache, Episodic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barrow Neurological Institute
  • Mayo Clinic in Arizona - Phoenix Campus
  • Keck School of Medicine of USC
  • Clinical Research Institute
  • Stanford Neurosciences Health Center
  • Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center
  • Yale New Haven Hospital
  • New England Institute for Neurology and Headache
  • Accel Research Sites - Tampa
  • Diamond Headache Clinic
  • Michigan Headache and Neurological Institute
  • Mayo Clinic - Rochester
  • The Headache Center Mississippi
  • Clinvest Research
  • Dartmouth-Hitchcock Medical Center
  • Dent Neurologic Institute - Amherst
  • New York University School of Medicine
  • Headache Wellness Center
  • Cleveland Clinic - Neurological Institute
  • The Ohio State University Wexner Medical Center
  • Hightower Clinical
  • Thomas Jefferson University Hospital - Center City Campus
  • Mischer Neuroscience Institute
  • Froedtert and Medical College of Wisconsin
  • Universitair Ziekenhuis Brussel
  • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
  • Centre Hospitalier Chretien - Clinique MontLégia
  • Mestska Nemocnice Ostrava
  • Fakultní Thomayerova nemocnice
  • FORBELI s.r.o. Neurologicka Ambulance
  • Institut Neuropsychiatrické Péce
  • Rigshospitalet Glostrup
  • Aarhus Universitetshospital
  • Hospitalsenhed Midt og Regionshospitalet Viborg
  • Sydvestjysk Sygehus - Esbjerg
  • Confido Meditsiinikeskus
  • Ida-Viru Keskhaigla
  • Tartu Ülikooli Kliinikum
  • Tampereen Yliopistollinen Sairaala (TAYS)
  • Terveystalo Ruoholahti
  • Terveystalo Turku Pulssi
  • Terveystalo Tampere
  • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Hôpital Cimiez
  • Hôpital Roger Salengro
  • Hôpital de la Timone
  • Centre Hospitalier Annecy Genevois
  • Centre Hospitalier Universitaire de Saint-Étienne
  • Hôpital Pierre Wertheimer
  • Hôpital Lariboisière
  • Pineo Medical Ecosystem
  • Archangel Saint Michael Multiprofile Clinical Hospital
  • Aversi Clinic - Central Branch
  • Simon Khechinashvili University Hospital
  • Consilium Medulla Multiprofile Clinic
  • Universität Heidelberg
  • LMU Klinikum - Campus Grosshadern
  • Kopfschmerzzentrum Frankfurt
  • Universitätsmedizin Rostock
  • Neurologische Praxis Dr. Stude
  • Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie
  • Universitätsklinikum Essen
  • Universitatsklinikum Carl Gustav Carus Dresden
  • Schmerzklinik Kiel
  • Charité Campus Mitte
  • Eginition University - General Hospital of Athens
  • 401 General Military Hospital of Athens
  • Mediterraneo Hospital
  • University General Hospital of Larissa
  • General Hospital of Patras Agios Andreas
  • Euromedica General Clinic - Thessaloniki
  • Azienda Ospedaliero - Universitaria Careggi
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
  • IRCCS Istituto Delle Scienze Neurologiche di Bologna
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
  • Azienda Ospedaliero - Universitaria di Modena
  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
  • Universita Campus Bio-Medico di Roma
  • Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
  • Sendai Headache And Neurology Clinic
  • Saitama Neuropsychiatric Institute
  • Japanese Red Cross Shizuoka Hospital
  • Canisius-Wilhelmina Ziekenhuis
  • Zuyderland Medisch Centrum Sittard-Geleen
  • Brain Research Center - Amsterdam
  • Oslo Hodepinesenter
  • St. Olavs Hospital - Universitetssykehuset I Trondheim
  • Hospital Prof. Doutor Fernando Fonseca
  • Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria
  • Hospital Garcia de Orta
  • Hospital da Luz
  • City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod
  • Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...
  • Kazan State Medical University
  • First Moscow State Medical University named after I.M. Sechenov
  • University Headache Clinic
  • LLC Scientific and Practical Medical Center Innovation and Health
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Universitario Virgen Macarena
  • Hospital Clinic de Barcelona
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen del Rocío
  • Hospital Universitari i Politècnic La Fe
  • Hospital Clínico Universitario de Valladolid
  • Hospital Clínico Universitario de Valencia
  • Hospital Clinico Universitario Lozano Blesa
  • Hallands sjukhus Halmstad
  • Skåneuro Privatmottagning
  • Karolinska Universitetssjukhuset Huddinge
  • Danderyds Sjukhus
  • Centralsjukhuset Karlstad
  • Hull University Teaching Hospitals NHS Trust
  • The Walton Centre NHS Foundation Trust
  • King's College Hospital NHS Foundation Trust
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • Northern Care Alliance NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1: Eptinezumab Then Placebo

Sequence 2: Placebo Then Eptinezumab

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-2

Secondary Outcome Measures

Percentage of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
Time From First Infusion of Investigation Medicinal Product (IMP) to Resolution of Cluster Headache Bout Within the First 4 Weeks
Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
Change From Baseline in the Number of Weekly Attacks to Week 1
Change From Baseline in the Number of Weekly Attacks to Week 2
Percentage of Participants With ≥50% Reduction From Baseline in Number of Attacks in Week 1
Percentage of Participants With ≥30% Reduction From Baseline in Number of Attacks in Week 1
Percentage of Participants With ≥30% Reduction in Number of Weekly Attacks Over Weeks 1-2
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of pain, Averaged Over Weeks 1-2
For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Change From Baseline to Week 1 in Integrated Measure of Frequency and Intensity of Pain
For Week 1 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
For Week 2 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain (Weeks 1-4)
For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Week) for Weeks 1, 2, 3, and 4
Change From Baseline in Number of Attacks for Weeks 3-4
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
Health Care Resource Utilization (HCRU) Score at Week 4
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Score at Week 4
General Health second version (WPAI:GH2.0) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)

Full Information

First Posted
December 24, 2020
Last Updated
October 18, 2023
Sponsor
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04688775
Brief Title
Eptinezumab in Participants With Episodic Cluster Headache
Acronym
ALLEVIATE
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache, Episodic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1: Eptinezumab Then Placebo
Arm Type
Experimental
Arm Description
Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period
Arm Title
Sequence 2: Placebo Then Eptinezumab
Arm Type
Experimental
Arm Description
Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
Eptinezumab - concentrate for solution for infusion, intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
Primary Outcome Measure Information:
Title
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-2
Time Frame
Baseline, Weeks 1-2
Secondary Outcome Measure Information:
Title
Percentage of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2
Time Frame
Baseline, Weeks 1-2
Title
Change From Baseline in the Number of Weekly Times an Abortive Medication Was Used, Averaged Over Weeks 1-2
Time Frame
Baseline, Weeks 1-2
Title
Change From Baseline in the Number of Daily Attacks, Averaged Over Days 1-3
Time Frame
Baseline, Days 1-3
Title
Change From Baseline in the Number of Days With <3 Attacks Per Day, Averaged Over Weeks 1-2
Time Frame
Baseline, Weeks 1-2
Title
Time From First Infusion of Investigation Medicinal Product (IMP) to Resolution of Cluster Headache Bout Within the First 4 Weeks
Time Frame
From Baseline to Week 4
Title
Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP
Time Frame
From first infusion (Day 0) to 24-hours post infusion
Title
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3
Time Frame
Baseline, Days 1-3
Title
Change From Baseline in the Number of Weekly Attacks to Week 1
Time Frame
Baseline, Week 1
Title
Change From Baseline in the Number of Weekly Attacks to Week 2
Time Frame
Baseline, Week 2
Title
Percentage of Participants With ≥50% Reduction From Baseline in Number of Attacks in Week 1
Time Frame
Baseline, Week 1
Title
Percentage of Participants With ≥30% Reduction From Baseline in Number of Attacks in Week 1
Time Frame
Baseline, Week 1
Title
Percentage of Participants With ≥30% Reduction in Number of Weekly Attacks Over Weeks 1-2
Time Frame
Baseline, Weeks 1-2
Title
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of pain, Averaged Over Weeks 1-2
Description
For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Time Frame
Baseline, Weeks 1-2
Title
Change From Baseline to Week 1 in Integrated Measure of Frequency and Intensity of Pain
Description
For Week 1 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Time Frame
Baseline, Week 1
Title
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain
Description
For Week 2 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Time Frame
Baseline, Week 2
Title
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4
Time Frame
Baseline, Weeks 1-4
Title
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain (Weeks 1-4)
Description
For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week.
Time Frame
Baseline, Weeks 1-4
Title
Change From Baseline in the Mean Score on 5-Point Self-Rating Pain Severity Scale (Average Per Week) for Weeks 1, 2, 3, and 4
Time Frame
Baseline, Weeks 1, 2, 3, and 4
Title
Change From Baseline in Number of Attacks for Weeks 3-4
Time Frame
Baseline, Weeks 3-4
Title
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4
Time Frame
Weeks 1, 2, and 4
Title
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4
Time Frame
Baseline, Weeks 2 and 4
Title
Change From Baseline in Euroqol 5-Dimension 5-Levels (EQ-5D-5L) Visual Analogue Scale (VAS) at Weeks 2 and 4
Time Frame
Baseline, Weeks 2 and 4
Title
Health Care Resource Utilization (HCRU) Score at Week 4
Time Frame
Week 4
Title
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Score at Week 4
Description
General Health second version (WPAI:GH2.0) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic in Arizona - Phoenix Campus
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Clinical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford Neurosciences Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-2483
Country
United States
Facility Name
New England Institute for Neurology and Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Accel Research Sites - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Michigan Headache and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104-5131
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Headache Center Mississippi
City
Ridgeland
State/Province
Mississippi
ZIP/Postal Code
39157
Country
United States
Facility Name
Clinvest Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Dent Neurologic Institute - Amherst
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Cleveland Clinic - Neurological Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hightower Clinical
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Thomas Jefferson University Hospital - Center City Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Mischer Neuroscience Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
State/Province
Bruxelles-Capitale
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Centre Hospitalier Chretien - Clinique MontLégia
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Mestska Nemocnice Ostrava
City
Ostrava
State/Province
Moravian-Silesian
ZIP/Postal Code
728 80
Country
Czechia
Facility Name
Fakultní Thomayerova nemocnice
City
Praha 4
State/Province
Prague
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
FORBELI s.r.o. Neurologicka Ambulance
City
Praha 6
State/Province
Prague
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Institut Neuropsychiatrické Péce
City
Praha 8
State/Province
Prague
ZIP/Postal Code
186 00
Country
Czechia
Facility Name
Rigshospitalet Glostrup
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Hospitalsenhed Midt og Regionshospitalet Viborg
City
Viborg
State/Province
Midtjylland
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Sydvestjysk Sygehus - Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Confido Meditsiinikeskus
City
Tallinn
State/Province
Harjumaa
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Ida-Viru Keskhaigla
City
Kohtla-Järve
State/Province
Ida-Virumaa
ZIP/Postal Code
31025
Country
Estonia
Facility Name
Tartu Ülikooli Kliinikum
City
Tartu
State/Province
Tartumaa
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Tampereen Yliopistollinen Sairaala (TAYS)
City
Tampere
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
33520
Country
Finland
Facility Name
Terveystalo Ruoholahti
City
Helsinki
State/Province
Southern Finland
ZIP/Postal Code
00180
Country
Finland
Facility Name
Terveystalo Turku Pulssi
City
Turku
State/Province
Western Finland
ZIP/Postal Code
20100
Country
Finland
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand Cedex 1
State/Province
Auvergne-Rhône-Alpes
ZIP/Postal Code
63003
Country
France
Facility Name
Hôpital Cimiez
City
Nice Cedex 1
State/Province
Côte-d'Or
ZIP/Postal Code
91179 - 06003
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital de la Timone
City
Marseille Cedex 5
State/Province
Provence Alpes Cote d'Azur
ZIP/Postal Code
13005
Country
France
Facility Name
Centre Hospitalier Annecy Genevois
City
Metz-Tessy
State/Province
Rhone-Alpes
ZIP/Postal Code
74370
Country
France
Facility Name
Centre Hospitalier Universitaire de Saint-Étienne
City
Saint-Priest-en-Jarez
State/Province
Rhône
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital Pierre Wertheimer
City
Bron
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75010
Country
France
Facility Name
Pineo Medical Ecosystem
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Facility Name
Archangel Saint Michael Multiprofile Clinical Hospital
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Aversi Clinic - Central Branch
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Simon Khechinashvili University Hospital
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Consilium Medulla Multiprofile Clinic
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Universität Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
LMU Klinikum - Campus Grosshadern
City
München
State/Province
Bayern
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt/ Main
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Facility Name
Universitätsmedizin Rostock
City
Rostock
State/Province
Mecklenburg-Western-Pommerania
ZIP/Postal Code
18147
Country
Germany
Facility Name
Neurologische Praxis Dr. Stude
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
Praxis für Neurologie, Psychosomatik, Nervenheilkunde, Psychotherapie und Spezielle Schmerztherapie
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45133
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitatsklinikum Carl Gustav Carus Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Schmerzklinik Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24149
Country
Germany
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Eginition University - General Hospital of Athens
City
Athens
State/Province
Attica
ZIP/Postal Code
11528
Country
Greece
Facility Name
401 General Military Hospital of Athens
City
Athina
State/Province
Attica
ZIP/Postal Code
115 25
Country
Greece
Facility Name
Mediterraneo Hospital
City
Glyfada
State/Province
Attica
ZIP/Postal Code
16675
Country
Greece
Facility Name
University General Hospital of Larissa
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece
Facility Name
General Hospital of Patras Agios Andreas
City
Patra
State/Province
Western Greece
ZIP/Postal Code
263 32
Country
Greece
Facility Name
Euromedica General Clinic - Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54645
Country
Greece
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Firenze
State/Province
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
City
Rome
State/Province
Roma
ZIP/Postal Code
00163
Country
Italy
Facility Name
Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Istituto Delle Scienze Neurologiche di Bologna
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
280138
Country
Italy
Facility Name
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Universita Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Name
Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Sendai Headache And Neurology Clinic
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Facility Name
Saitama Neuropsychiatric Institute
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Facility Name
Japanese Red Cross Shizuoka Hospital
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum Sittard-Geleen
City
Geleen
State/Province
Limburg
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Brain Research Center - Amsterdam
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Oslo Hodepinesenter
City
Oslo
ZIP/Postal Code
0275
Country
Norway
Facility Name
St. Olavs Hospital - Universitetssykehuset I Trondheim
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Hospital Prof. Doutor Fernando Fonseca
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2720-276
Country
Portugal
Facility Name
Centro Hospitalar Universitario Lisboa Norte, E.P.E - Hospital De Santa Maria
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Garcia de Orta
City
Almada
State/Province
Setúbal
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Hospital da Luz
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Facility Name
City Hospital No. 33 of the Leninsky District of the city of Nizhny Novgorod
City
Nizhnij Novgorod
State/Province
Nizhegorodskaya Oblast
ZIP/Postal Code
603076
Country
Russian Federation
Facility Name
Perm State Medical University named after E. A. Wagner of the Ministry of Healthcare of the Russi...
City
Perm
State/Province
Permsky
ZIP/Postal Code
614990
Country
Russian Federation
Facility Name
Kazan State Medical University
City
Kazan
State/Province
Tartarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
First Moscow State Medical University named after I.M. Sechenov
City
Moscow
ZIP/Postal Code
119146
Country
Russian Federation
Facility Name
University Headache Clinic
City
Moscow
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
LLC Scientific and Practical Medical Center Innovation and Health
City
Novosibirsk
ZIP/Postal Code
630054
Country
Russian Federation
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena
City
Castilleja de la Cuesta
State/Province
Sevilla
ZIP/Postal Code
41950
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
València
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hallands sjukhus Halmstad
City
Halmstad
State/Province
Hallands Län
ZIP/Postal Code
301 85
Country
Sweden
Facility Name
Skåneuro Privatmottagning
City
Lund
State/Province
Skåne Län
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge
City
Huddinge
State/Province
Stockholms Län
ZIP/Postal Code
141 57
Country
Sweden
Facility Name
Danderyds Sjukhus
City
Stockholm
State/Province
Stockholms Län
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Centralsjukhuset Karlstad
City
Karlstad
State/Province
Värmlands Län
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
The Walton Centre NHS Foundation Trust
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle-upon-Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Northern Care Alliance NHS Foundation Trust
City
Salford
State/Province
England
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Eptinezumab in Participants With Episodic Cluster Headache

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