Clinical trial NCT05064397: A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
Official title: Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Cluster Headache
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.

Detailed description: The participants who take part in this trial will be asked to stay in the trial for about a year. The participants will be asked to visit the trial site 7 times during the trial. In between trial site visits, they will have scheduled phone calls with the trial site staff. They will also be asked to keep track of their cluster headaches at home with a headache diary.

Eligibility criteria: Inclusion Criteria:

* The participant has a diagnosis of cCH as defined by International Headache Society (IHS) International Classification of Headache Disorders third edition (ICHD-3) classification with a history of cCH of at least 12 months prior to the Screening Visit.
* The participant has a medical history of onset of cluster headache at ≤50 years of age.
* The participant has an adequately documented record of previous abortive, transitional and preventive medication use for cCH, for at least 12 months prior to the Screening Visit.
* The participant is able to distinguish cluster headache attacks from other headaches (such as tension-type headaches, migraine).

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 chronic tension-type headache, 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 neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or longer than 1 hour).
* Participants with a lifetime history of psychosis, bipolar mania, or dementia. 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.
* The participant has attempted suicide or is, at Screening Visit, at significant risk of suicide.
* The participant has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (AEs)
timeFrame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Secondary outcomes:
measure: Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache (eCH): Number of Participants With No Cluster Headache (CH) Attacks for ≥3 Consecutive Months (≥12 Consecutive Weeks)
timeFrame: Week 1 to Week 48
measure: Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Change From Baseline in the Average Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Change From Baseline in the Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1-4
measure: Change From Baseline in the Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1-2
measure: Change From Baseline in the Number of Monthly Attacks
timeFrame: Baseline (Week 0), Months 1-12
measure: Change From Baseline in the Average Attack Related Daily Pain (Including Days With no Attacks), as Assessed Using the 5-point Self-rating Pain Severity Scale
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
timeFrame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
measure: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
timeFrame: Week 1 to Week 48
measure: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)
timeFrame: Week 1 to Week 12
measure: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)
timeFrame: Week 13 to Week 24
measure: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
timeFrame: Week 25 to Week 36
measure: cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
timeFrame: Week 37 to Week 48
measure: Number of Participants Who Received a Transitional Therapy During the Treatment Period
timeFrame: Week 1 to Week 48
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
measure: Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
timeFrame: Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48
measure: Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Change From Baseline in the Work Productivity Activity Impairment: General Health Second Version (WPAI:GH2.0) Sub-Scores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Weeks 4, 16, 28, 40 and 48
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Health Care Resource Utilization - Number of Visits to a Specialist
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
measure: Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
timeFrame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Other outcomes:
Locations:
city: Stamford
country: United States
facility: New England Institute for Neurology and Headache
state: Connecticut
city: Ann Arbor
country: United States
facility: Michigan Headache and Neurological Institute
state: Michigan
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic - Neurological Institute
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital - Center City Campus
state: Pennsylvania
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
state: Hovedstaden
city: Viborg
country: Denmark
facility: Hospitalsenhed Midt og Regionshospitalet Viborg
state: Midtjylland
city: Helsinki
country: Finland
facility: Terveystalo Ruoholahti
state: Southern Finland
city: Turku
country: Finland
facility: Terveystalo Turku Pulssi
state: Western Finland
city: Nice Cedex 1
country: France
facility: Hôpital Cimiez
state: Côte-d'Or
city: Lille
country: France
facility: Hôpital Roger Salengro
state: Nord
city: Marseille Cedex 5
country: France
facility: Hôpital de la Timone
state: Provence Alpes Cote d'Azur
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
state: Rhône
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint-Étienne
state: Rhône
city: Paris
country: France
facility: Hôpital Lariboisière
state: Île-de-France
city: Frankfurt/ Main
country: Germany
facility: Kopfschmerzzentrum Frankfurt
state: Hessen
city: Berlin
country: Germany
facility: Charité Campus Mitte
city: Milano
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
state: Milan
city: Rome
country: Italy
facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
state: Roma
city: Bologna
country: Italy
facility: IRCCS Istituto Delle Scienze Neurologiche di Bologna
city: Pavia
country: Italy
facility: Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
city: Turin
country: Italy
facility: Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Brain Research Center - Amsterdam
state: Noord-Holland
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: València
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: England
Study officials:
affiliation: H. Lundbeck A/S
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: