Eptinezumab in Participants With Episodic Cluster Headache (ALLEVIATE)

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

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

Study Overview

• Status: Completed
• Conditions: Cluster Headache, Episodic
• Intervention / Treatment: Drug: Eptinezumab; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: Eptinezumab Then Placebo; Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period	Drug: Eptinezumab; Eptinezumab - concentrate for solution for infusion, intravenously; Drug: Placebo; Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously
Experimental: Sequence 2: Placebo Then Eptinezumab; Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period	Drug: Eptinezumab; Eptinezumab - concentrate for solution for infusion, intravenously; Drug: Placebo; Placebo - 100 milliliters (mL) of 0.9% normal saline, intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Abortive medications included the use of triptans or oxygen (O2).	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	Presented here is the result of the analysis of time from first infusion of IMP to resolution of cluster headache bout. The hazard ratio estimate is an estimate from the Cox model of time to resolution.	From first infusion (Baseline, Day 0) to 4 weeks
Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP		From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period
Change From Baseline in the Daily Mean Score on 5-Point Self-Rating Pain Severity Scale, Averaged Over Days 1-3	The severity of pain was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).	Baseline (Week 0), Days 1-3
Change From Baseline to Week 1 in the Number of Weekly Attacks		Baseline (Week 0), Week 1
Change From Baseline to Week 2 in the Number of Weekly Attacks		Baseline (Week 0), Week 2
Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1		Baseline (Week 0), Week 1
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1		Baseline (Week 0), Week 1
Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2		Baseline (Week 0), Weeks 1-2
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-2	The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.	Baseline (Week 0), Weeks 1-2
Change From Baseline to Week 1 in Weekly Integrated Measure of Frequency and Intensity of Pain	The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.	Baseline (Week 0), Week 1
Change From Baseline to Week 2 in Weekly Integrated Measure of Frequency and Intensity of Pain	The weekly integrated measure of frequency and intensity of pain calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.	Baseline (Week 0), Week 2
Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4		Baseline (Week 0), Weeks 1-4
Change From Baseline in Weekly Integrated Measure of Frequency and Intensity of Pain, Averaged Over Weeks 1-4	The weekly integrated measure of frequency and intensity of pain score calculates a singular numerical value for frequency and intensity of pain by adding the intensity rating (Worst pain on a 5-point Self-rating pain severity scale) for each attack during that week. The intensity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating). The total weekly score could range from 0 (no attacks and/or no pain) to no specified upper limit, with lower scores representing better outcomes.	Baseline (Week 0), Weeks 1-4
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	The severity of pain for each attack was rated on an ordinal scale that ranged from 0 to 4 with higher scores indicating more headache pain (headache pain ratings: 0 = none/barely any pain; 1 = mild; 2 = moderate; 3 = severe; 4 = excruciating).	Baseline (Week 0), Weeks 1, 2, 3, and 4
Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4		Baseline (Week 0), Weeks 3-4
Patient Global Impression of Change (PGIC) Score at Weeks 1, 2, and 4	The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate better health status.	Weeks 1, 2, and 4
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores at Weeks 2 and 4	The SIS is a patient-reported clinical outcome assessment used to assess quality of life resulting from sleep disturbance. The SIS questionnaire includes 35 items belonging to 7 domains to assess sleep impact on: daily activities; emotional well-being; emotional impact; energy/fatigue; social well-being; mental fatigue; and satisfaction with sleep. Each item, for 6 out of the 7 domains, is rated on a 5-point scale ranging from 1 (always or all of the time) to 5 (never or none of the time), whereas satisfaction with sleep is rated on a 5-point scale ranging from 1 (very satisfied) to 5 (very dissatisfied). Each domain yields a score ranging from 0 to 100, which is presented here. A higher score for Daily Activities, Emotional Well-being, Emotional Impact, Energy/Fatigue, Social Well-being, and Mental Fatigue indicates better quality of life. A lower score for Satisfaction with Sleep indicates a higher quality of life.	Baseline (Week 0), 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	The EQ-5D-5L VAS is a participant-reported assessment designed to measure the participant's well-being and ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline (Week 0), Weeks 2 and 4
Health Care Resource Utilization (HCRU) Score: Number of Visits to a Family Doctor/General Practitioner	Number of participants who visited a family doctor/general practitioner has been reported.	Week 4
HCRU Score: Number of Visits to a Specialist	Number of participants who visited a specialist has been reported.	Week 4
HCRU Score: Number of Emergency Department Visits Due to Cluster Headache	Number of participants who visited an emergency department due to CH was reported.	Week 4
HCRU Score: Number of Hospital Admissions Due to Cluster Headache	Number of participants who were admitted to a hospital due to CH was reported.	Week 4
HCRU Score: Number of Overnight Hospital Stays Due to Cluster Headache	Number of participants who stayed overnight in a hospital due to CH was reported.	Week 4
Change From Baseline in the Work Productivity Activity Impairment (WPAI) Questionnaire Subscores at Week 4	The WPAI:GH2.0 is a patient self-rated clinical outcome assessment designed to provide a quantitative measure of the work productivity and activity impairment due to a health condition. The WPAI:GH2.0 assesses activities over the preceding 7 days and consists of 6 items: 1 item assesses employment (yes/no); 3 items assess the number of hours worked, the number of hours missed from work due to the participant's condition, or due to other reasons; and 2 visual numerical scales assess how much the participant's condition affects his/her productivity at work and his/her ability to complete normal daily activities. Each item (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) was calculated into an impairment percentage ranging from 0 to 100%, with higher numbers indicating greater impairment and less productivity (i.e. worse outcomes). Change from baseline for each item is shown here.	Baseline (Week 0), Week 4

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2020
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Cluster Headache
• Other Study ID Numbers: 19386A

Drug and device information, study documents

• 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