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AzTrials

Cluster Headache, EpisodicPhase 3ALLEVIATENCT04688775

Eptinezumab in Participants With Episodic Cluster Headache

A Phase 3 study testing Eptinezumab in people with Cluster Headache, Episodic, run by H. Lundbeck A/S at 120 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cluster Headache, Episodic
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
231 participants
Where
120 sitesin 19 countries
Study dates
23 Dec 2020to 5 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

120 sites in 19 countries.

120 sites in 19 countries

United States24 sites

  • Dent Neurologic Institute - Amherst

    Amherst, New York, 14226

  • Michigan Headache and Neurological Institute

    Ann Arbor, Michigan, 48104-5131

  • Diamond Headache Clinic

    Chicago, Illinois, 60642

  • Cleveland Clinic - Neurological Institute

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Neurology Colorado - Denver Advanced Neurological Evaluation and Treatment Center

    Denver, Colorado, 80218

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • Mischer Neuroscience Institute

    Houston, Texas, 77030

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

  • Clinical Research Institute

    Los Angeles, California, 90048

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510-2483

  • New York University School of Medicine

    New York, New York, 10016

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73134

  • Stanford Neurosciences Health Center

    Palo Alto, California, 94304

  • Thomas Jefferson University Hospital - Center City Campus

    Philadelphia, Pennsylvania, 19107

  • Barrow Neurological Institute

    Phoenix, Arizona, 85013

  • Mayo Clinic in Arizona - Phoenix Campus

    Phoenix, Arizona, 85054

  • The Headache Center Mississippi

    Ridgeland, Mississippi, 39157

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Clinvest Research

    Springfield, Missouri, 65810

  • New England Institute for Neurology and Headache

    Stamford, Connecticut, 06905

  • Accel Research Sites - Tampa

    Tampa, Florida, 33634

Other trials in United States

Spain11 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08017

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Virgen Macarena

    Castilleja de la Cuesta, Sevilla, 41950

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Germany10 sites

  • Charité Campus Mitte

    Berlin, 10117

  • Neurologische Praxis Dr. Stude

    Bochum, North Rhine-Westphalia, 44787

  • Universitatsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

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

    Essen, North Rhine-Westphalia, 45133

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • Kopfschmerzzentrum Frankfurt

    Frankfurt am Main, Hesse, 65929

  • Universität Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Schmerzklinik Kiel

    Kiel, Schleswig-Holstein, 24149

  • LMU Klinikum - Campus Grosshadern

    München, Bavaria, D-81377

  • Universitätsmedizin Rostock

    Rostock, Mecklenburg-Western-Pommerania, 18147

Other trials in Germany

Italy10 sites

  • Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

    Bari, 70124

  • IRCCS Istituto Delle Scienze Neurologiche di Bologna

    Bologna, 40123

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, Florence, 50134

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

    Milan, 20133

  • Azienda Ospedaliero - Universitaria di Modena

    Modena, 41124

  • Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli

    Naples, 280138

  • Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS

    Pavia, 27100

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

    Rome, Roma, 00163

  • Universita Campus Bio-Medico di Roma

    Rome, 00128

  • Ospedale Molinette - Clinica Neurologica II - Centro Cefalee

    Turin, 10126

Other trials in Italy

France8 sites

  • Hôpital Pierre Wertheimer

    Bron

  • Centre Hospitalier Universitaire de Clermont-Ferrand

    Clermont-Ferrand, Auvergne-Rhône-Alpes, 63003

  • Hôpital Roger Salengro

    Lille, Nord, 59037

  • Hôpital de la Timone

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

  • Centre Hospitalier Annecy Genevois

    Metz-Tessy, Auvergne-Rhône-Alpes, 74370

  • Hôpital Cimiez

    Nice, Côte-d'Or, 91179 - 06003

  • Hôpital Lariboisière

    Paris, Île-de-France Region, 75010

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Priest-en-Jarez, Rhône, 42055

Other trials in France

Greece6 sites

  • 401 General Military Hospital of Athens

    Athens, Attica, 115 25

  • Eginition University - General Hospital of Athens

    Athens, Attica, 11528

  • Mediterraneo Hospital

    Glyfada, Attica, 16675

  • University General Hospital of Larissa

    Larissa, Thessaly, 41110

  • General Hospital of Patras Agios Andreas

    Pátrai, West Greece, 263 32

  • Euromedica General Clinic - Thessaloniki

    Thessaloniki, 54645

Other trials in Greece

Russia6 sites

  • Kazan State Medical University

    Kazan', Tartarstan, 420012

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

    Moscow, 119146

  • University Headache Clinic

    Moscow, 121467

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

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603076

  • LLC Scientific and Practical Medical Center Innovation and Health

    Novosibirsk, 630054

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

    Perm, Permsky, 614990

Other trials in Russia

Georgia5 sites

  • Pineo Medical Ecosystem

    Tbilisi, 0114

  • Archangel Saint Michael Multiprofile Clinical Hospital

    Tbilisi, 0159

  • Aversi Clinic - Central Branch

    Tbilisi, 0160

  • Simon Khechinashvili University Hospital

    Tbilisi, 0179

  • Consilium Medulla Multiprofile Clinic

    Tbilisi, 0186

Other trials in Georgia

Sweden5 sites

  • Hallands sjukhus Halmstad

    Halmstad, Halland County, 301 85

  • Karolinska Universitetssjukhuset Huddinge

    Huddinge, Stockholm County, 141 57

  • Centralsjukhuset Karlstad

    Karlstad, Värmland County, 651 85

  • Skåneuro Privatmottagning

    Lund, Skåne County, 222 22

  • Danderyds Sjukhus

    Stockholm, Stockholm County, 182 88

Other trials in Sweden

United Kingdom5 sites

  • Hull University Teaching Hospitals NHS Trust

    Hull, England, HU3 2JZ

  • The Walton Centre NHS Foundation Trust

    Liverpool, England, L9 7LJ

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9PJ

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, England, NE7 7DN

  • Northern Care Alliance NHS Foundation Trust

    Salford, England, M6 8HD

Other trials in United Kingdom

Czechia4 sites

  • Mestska Nemocnice Ostrava

    Ostrava, Moravian-Silesian, 728 80

  • Fakultní Thomayerova nemocnice

    Prague, Prague, 140 59

  • FORBELI s.r.o. Neurologicka Ambulance

    Prague, Prague, 160 00

  • Institut Neuropsychiatrické Péce

    Prague, Prague, 186 00

Other trials in Czechia

Denmark4 sites

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland, 8200

  • Sydvestjysk Sygehus - Esbjerg

    Esbjerg, 6700

  • Rigshospitalet Glostrup

    Glostrup Municipality, Capital Region, 2600

  • Hospitalsenhed Midt og Regionshospitalet Viborg

    Viborg, Central Jutland, 8800

Other trials in Denmark

Finland4 sites

  • Terveystalo Ruoholahti

    Helsinki, Southern Finland, 00180

  • Tampereen Yliopistollinen Sairaala (TAYS)

    Tampere, Länsi-Suomen Lääni, 33520

  • Terveystalo Tampere

    Tampere, 33100

  • Terveystalo Turku Pulssi

    Turku, Western Finland, 20100

Other trials in Finland

Portugal4 sites

  • Hospital Garcia de Orta

    Almada, Setúbal District, 2805-267

  • Hospital Prof. Doutor Fernando Fonseca

    Amadora, Lisbon District, 2720-276

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

    Lisbon, Lisbon District, 1649-035

  • Hospital da Luz

    Lisbon, 1500-650

Other trials in Portugal

Belgium3 sites

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

    Bruges, West-Vlaanderen, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, Brussels Capital, 1090

  • Centre Hospitalier Chretien - Clinique MontLégia

    Liège, 4000

Other trials in Belgium

Estonia3 sites

  • Ida-Viru Keskhaigla

    Kohtla-Järve, Ida-Virumaa, 31025

  • Confido Meditsiinikeskus

    Tallinn, Harju, 10138

  • Tartu Ülikooli Kliinikum

    Tartu, Tartu, 50406

Other trials in Estonia

Japan3 sites

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577

  • Sendai Headache And Neurology Clinic

    Sendai, Miyagi, 982-0014

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, Shizuoka, 420-0853

Other trials in Japan

Netherlands3 sites

  • Brain Research Center - Amsterdam

    Amsterdam, North Holland, 1081 GN

  • Zuyderland Medisch Centrum Sittard-Geleen

    Geleen, Limburg, 6162 BG

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

Other trials in Netherlands

Norway2 sites

  • Oslo Hodepinesenter

    Oslo, 0275

  • St. Olavs Hospital - Universitetssykehuset I Trondheim

    Trondheim, 7030

Other trials in Norway

About this study

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

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

Read the 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.

Being tested
Eptinezumab, Placebo
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Eptinezumab - concentrate for solution for infusion, intravenously

  • PlaceboDrug

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

Study groups in NCT04688775
Study groupRoleWhat they receive
Sequence 1: Eptinezumab Then PlaceboExperimentalEptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period
Receives: Drug: Eptinezumab; Drug: Placebo
Sequence 2: Placebo Then EptinezumabExperimentalPlacebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period
Receives: Drug: Eptinezumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0), Weeks 1-2

Secondary outcomes (28)

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

    Measured: Baseline (Week 0), Weeks 1-2

  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).

    Measured: Baseline (Week 0), Weeks 1-2

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

    Measured: Baseline (Week 0), Days 1-3

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

    Measured: Baseline (Week 0), Weeks 1-2

  5. 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.

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

  6. Change From Baseline in Number of Attacks Starting ≤24 Hours After the Start of the First Infusion of IMP

    Measured: From first infusion in the placebo-controlled period (Baseline, Day 0) to 24-hours after the first infusion in the placebo-controlled period

  7. 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).

    Measured: Baseline (Week 0), Days 1-3

  8. Change From Baseline to Week 1 in the Number of Weekly Attacks

    Measured: Baseline (Week 0), Week 1

  9. Change From Baseline to Week 2 in the Number of Weekly Attacks

    Measured: Baseline (Week 0), Week 2

  10. Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks in Week 1

    Measured: Baseline (Week 0), Week 1

  11. Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks in Week 1

    Measured: Baseline (Week 0), Week 1

  12. Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Over Weeks 1-2

    Measured: Baseline (Week 0), Weeks 1-2

  13. 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.

    Measured: Baseline (Week 0), Weeks 1-2

  14. 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.

    Measured: Baseline (Week 0), Week 1

  15. 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.

    Measured: Baseline (Week 0), Week 2

  16. Change From Baseline in the Number of Weekly Attacks, Averaged Over Weeks 1-4

    Measured: Baseline (Week 0), Weeks 1-4

  17. 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.

    Measured: Baseline (Week 0), Weeks 1-4

  18. 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).

    Measured: Baseline (Week 0), Weeks 1, 2, 3, and 4

  19. Change From Baseline in the Number of Weekly Attacks for Each of Weeks 3 and 4

    Measured: Baseline (Week 0), Weeks 3-4

  20. 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.

    Measured: Weeks 1, 2, and 4

  21. 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.

    Measured: Baseline (Week 0), Weeks 2 and 4

  22. 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).

    Measured: Baseline (Week 0), Weeks 2 and 4

  23. 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.

    Measured: Week 4

  24. HCRU Score: Number of Visits to a Specialist

    Number of participants who visited a specialist has been reported.

    Measured: Week 4

  25. HCRU Score: Number of Emergency Department Visits Due to Cluster Headache

    Number of participants who visited an emergency department due to CH was reported.

    Measured: Week 4

  26. HCRU Score: Number of Hospital Admissions Due to Cluster Headache

    Number of participants who were admitted to a hospital due to CH was reported.

    Measured: Week 4

  27. 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.

    Measured: Week 4

  28. 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.

    Measured: Baseline (Week 0), Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start23 Dec 2020
  3. Primary completion14 Jun 2023
  4. Study completion5 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04688775
Sponsor's protocol ID
19386A
Acronym
ALLEVIATE
Status last verified
Jul 2024
First submitted
24 Dec 2020
Last updated
9 Aug 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40388178

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Cluster Headache, Episodic, run by H. Lundbeck A/S at 120 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Spain, Germany, Italy, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Number of Weekly Cluster Headache (CH) Attacks, Averaged Over Weeks 1-2 (time frame: Baseline (Week 0), Weeks 1-2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04688775, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

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