Back to resultsA 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) (CHRONICLE)
Primary Purpose
Chronic Cluster Headache
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eptinezumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Cluster Headache
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.
Sites / Locations
- New England Institute for Neurology and Headache
- Michigan Headache and Neurological Institute
- Dent Neurologic Institute - Amherst
- Cleveland Clinic - Neurological Institute
- Thomas Jefferson University Hospital - Center City Campus
- Rigshospitalet Glostrup
- Hospitalsenhed Midt og Regionshospitalet Viborg
- Terveystalo Ruoholahti
- Terveystalo Turku Pulssi
- Hôpital Cimiez
- Hôpital Roger Salengro
- Hôpital de la Timone
- Hôpital Pierre Wertheimer
- Centre Hospitalier Universitaire de Saint-Étienne
- Hôpital Lariboisière
- Kopfschmerzzentrum Frankfurt
- Charité Campus Mitte
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana
- IRCCS Istituto Delle Scienze Neurologiche di Bologna
- Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
- Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
- Canisius-Wilhelmina Ziekenhuis
- Brain Research Center - Amsterdam
- Hospital Universitario Marques de Valdecilla
- Hospital Universitari Vall d'Hebron
- Hospital Universitario Virgen del Rocío
- Hospital Clínico Universitario de Valladolid
- Hospital Clínico Universitario de Valencia
- The Walton Centre NHS Foundation Trust
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eptinezumab
Arm Description
Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache: Number of Participants With No Cluster Headache Attacks for ≥3 Consecutive Months (≥13 Consecutive Weeks)
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used, Averaged Over the First 4 Weeks After Each Infusion
Change From Baseline in the Average Number of Weekly Attacks, Averaged Over the First 4 Weeks After Each Infusion
Change From Baseline in the 5-Point Self-Rating Pain Severity Scale, Averaged Over the First 4 Weeks After Each Infusion
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the First and Second Infusion)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Second and Third Infusion)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Third and Fourth Infusion)
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
Number of Participants who Received a Transitional Therapy During the Treatment Period
Patient Global Impression of Change (PGIC) Score
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Health Care Resources Utilization (HCRU) Score
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05064397
Brief Title
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
Acronym
CHRONICLE
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cluster Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eptinezumab
Arm Type
Experimental
Arm Description
Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36.
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Other Intervention Name(s)
Vyepti
Intervention Description
Eptinezumab will be administered per schedule specified in the arm description.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Secondary Outcome Measure Information:
Title
Conversion From Chronic Cluster Headache (cCH) to Episodic Cluster Headache: Number of Participants With No Cluster Headache Attacks for ≥3 Consecutive Months (≥13 Consecutive Weeks)
Time Frame
Baseline (Week 0) to Week 48
Title
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used, Averaged Over the First 4 Weeks After Each Infusion
Time Frame
Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Title
Change From Baseline in the Average Number of Weekly Attacks, Averaged Over the First 4 Weeks After Each Infusion
Time Frame
Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Title
Change From Baseline in the 5-Point Self-Rating Pain Severity Scale, Averaged Over the First 4 Weeks After Each Infusion
Time Frame
Baseline (Week 0), Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Title
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
Time Frame
Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Title
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion
Time Frame
Weeks 1 to 4, 13 to 16, 25 to 28, and 37 to 40
Title
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks)
Time Frame
Baseline (Week 0) to Week 48
Title
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the First and Second Infusion)
Time Frame
Baseline (Week 0) to Week 12
Title
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Second and Third Infusion)
Time Frame
Week 12 to Week 24
Title
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Between the Third and Fourth Infusion)
Time Frame
Week 24 to Week 36
Title
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (5 Consecutive Weeks Within the First 12 Weeks After the Fourth Infusion)
Time Frame
Week 36 to Week 48
Title
Number of Participants who Received a Transitional Therapy During the Treatment Period
Time Frame
Week 0 to Week 48
Title
Patient Global Impression of Change (PGIC) Score
Time Frame
Baseline (Week 0) up to Week 48
Title
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Time Frame
Baseline (Week 0) up to Week 40
Title
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
Time Frame
Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
Title
Health Care Resources Utilization (HCRU) Score
Time Frame
Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
Title
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
Time Frame
Baseline (Week 0) , Weeks 4, 16, 28, 40 and 48
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
H. Lundbeck A/S
Official's Role
Study Director
Facility Information:
Facility Name
New England Institute for Neurology and Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
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
Dent Neurologic Institute - Amherst
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Cleveland Clinic - Neurological Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Rigshospitalet Glostrup
City
Glostrup
State/Province
Hovedstaden
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Hospitalsenhed Midt og Regionshospitalet Viborg
City
Viborg
State/Province
Midtjylland
ZIP/Postal Code
8800
Country
Denmark
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
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
Hôpital Pierre Wertheimer
City
Bron
State/Province
Rhône
ZIP/Postal Code
69677
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 Lariboisière
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75010
Country
France
Facility Name
Kopfschmerzzentrum Frankfurt
City
Frankfurt/ Main
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
City
Milano
State/Province
Milan
ZIP/Postal Code
20133
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
IRCCS Istituto Delle Scienze Neurologiche di Bologna
City
Bologna
ZIP/Postal Code
40123
Country
Italy
Facility Name
Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Brain Research Center - Amsterdam
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 GN
Country
Netherlands
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
València
ZIP/Postal Code
46010
Country
Spain
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 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
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