Chronic Cluster HeadachePhase 3CHRONICLENCT05064397
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
A Phase 3 study testing Eptinezumab in people with Chronic Cluster Headache, run by H. Lundbeck A/S at 31 sites in 9 countries.
Trial summary
The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Cluster Headache
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 17 Sep 2021to 29 Jun 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 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).
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 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.
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
France6 sites
Hôpital Pierre Wertheimer
Bron, Rhône, 69677
Hôpital Roger Salengro
Lille, Nord, 59037
Hôpital de la Timone
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
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
United States5 sites
Dent Neurologic Institute - Amherst
Amherst, New York, 14226
Michigan Headache and Neurological Institute
Ann Arbor, Michigan, 48104-5131
Cleveland Clinic - Neurological Institute
Cleveland, Ohio, 44195
Thomas Jefferson University Hospital - Center City Campus
Philadelphia, Pennsylvania, 19107
New England Institute for Neurology and Headache
Stamford, Connecticut, 06905
Italy5 sites
IRCCS Istituto Delle Scienze Neurologiche di Bologna
Bologna, 40123
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Fondazione Istituto Neurologico Car...
Milan, Milan, 20133
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
Ospedale Molinette - Clinica Neurologica II - Centro Cefalee
Turin, 10126
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital Clínico Universitario de Valladolid
Valladolid, 47010
Denmark2 sites
Rigshospitalet Glostrup
Glostrup Municipality, Capital Region, 2600
Hospitalsenhed Midt og Regionshospitalet Viborg
Viborg, Central Jutland, 8800
Finland2 sites
Terveystalo Ruoholahti
Helsinki, Southern Finland, 00180
Terveystalo Turku Pulssi
Turku, Western Finland, 20100
Germany2 sites
Charité Campus Mitte
Berlin, 10117
Kopfschmerzzentrum Frankfurt
Frankfurt am Main, Hesse, 65929
Netherlands2 sites
Brain Research Center - Amsterdam
Amsterdam, North Holland, 1081 GN
Canisius-Wilhelmina Ziekenhuis
Nijmegen, Gelderland, 6532 SZ
United Kingdom2 sites
The Walton Centre NHS Foundation Trust
Liverpool, England, L9 7LJ
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
About this study
Official title: Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache
The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.
Read the 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.
- Conditions
- Chronic Cluster Headache
- Being tested
- Eptinezumab
- 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
Also called Vyepti
Eptinezumab will be administered per schedule specified in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab | Experimental | Participants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36. Receives: Drug: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (AEs)
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
Secondary outcomes (28)
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)
Participants counted as converting from cCH to eCH if they had no CH attacks for at least 3 months.
Measured: Week 1 to Week 48
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Abortive therapy was defined as oxygen and/or triptans, where it counted as 2 times if oxygen and triptans were used for the same attack.
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Average Number of Weekly Attacks
The participant completed a CH eDiary, daily, and record for each day/week whether he/she had any CH attacks.
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Number of Weekly Attacks
The average of the estimated change from baseline in the number of weekly attacks across the first 4 weeks after the infusion is shown.
Measured: Baseline (Week 0), Weeks 1-4
Change From Baseline in the Number of Weekly Attacks
The average of the estimated change from baseline in the number of weekly attacks across the first 2 weeks after the infusion is shown.
Measured: Baseline (Week 0), Weeks 1-2
Change From Baseline in the Number of Monthly Attacks
The average of the estimated change from baseline in the number of monthly attacks across the first 12 months after the infusion is shown.
Measured: Baseline (Week 0), Months 1-12
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
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, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Measured: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
Participants counted as being in remission if they had no cluster headache attacks for at least 1 month.
Measured: Week 1 to Week 48
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)
Measured: Week 1 to Week 12
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)
Measured: Week 13 to Week 24
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
Measured: Week 25 to Week 36
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)
Measured: Week 37 to Week 48
Number of Participants Who Received a Transitional Therapy During the Treatment Period
Transitional treatments were defined as greater occipital nerve (GON) block or oral steroids.
Measured: Week 1 to Week 48
Patient Global Impression of Change (PGIC) Score
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 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
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 4, 12, 16, 24, 28, 36, 40, 48
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48
The EQ-5D-5L is a patient-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety). Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems).
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
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 4, 16, 28, 40, 48
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
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), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Number of participants who visited a family doctor/general practitioner has been reported.
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Visits to a Specialist
Number of participants who visited a specialist has been reported.
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Number of participants who visited an emergency department due to CH has been reported.
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Number of participants admitted to the hospital due to CH has been reported.
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Number of participants who had overnight hospital stays due to CH has been reported.
Measured: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start17 Sep 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064397
- Sponsor's protocol ID
- 19385A
- Acronym
- CHRONICLE
- Status last verified
- Jul 2024
- First submitted
- 22 Sep 2021
- Last updated
- 6 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tassorelli C, Jensen RH, Goadsby PJ, Charles AC, Tepper SJ, Snoer AH, Josiassen MK, Linander CB, Ettrup A, Sperling B, Boneva N. Long-term safety, tolerability, and efficacy of eptinezumab in chronic cluster headache (CHRONICLE): an open-label safety trial. Lancet Neurol. 2025 May;24(5):429-440. doi: 10.1016/S1474-4422(25)00065-1.
PubMed 40252664
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Open-label, Fixed-dose Multiple Administration Study to Evaluate Long-term Treatment With Eptinezumab in Patients With Chronic Cluster Headache
- ClinicalTrials.gov ID
- NCT05064397
- Acronym / sponsor ID
- CHRONICLE / 19385A
- Conditions
- Chronic Cluster Headache
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 6 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab | Experimental | Drug: EptinezumabParticipants will receive 4 intravenous (IV) infusions with eptinezumab at Baseline (Day 0) and at the end of Weeks 12, 24, and 36. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EptinezumabAlso: VyeptiEptinezumab will be administered per schedule specified in the arm description. | Drug | Eptinezumab |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (AEs)
Time frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56
A treatment-emergent AE was defined as any on-treatment untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
28 secondary outcomes
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)
Time frame: Week 1 to Week 48
Change From Baseline in Weekly Number of Times an Abortive Therapy (Oxygen and/or Triptans) Was Used
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Oxygen) Was Used
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in Weekly Number of Times An Abortive Therapy (Triptans) Were Used
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Average Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Change From Baseline in the Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1-4
Change From Baseline in the Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1-2
Change From Baseline in the Number of Monthly Attacks
Time frame: Baseline (Week 0), Months 1-12
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
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥30% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥50% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
Response: Number of Participants With ≥75% Reduction From Baseline in Number of Weekly Attacks
Time frame: Baseline (Week 0), Weeks 1, 2, 3, 4, 13, 14, 15, 16, 25, 26, 27, 28, 37, 38, 39, 40
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks)
Time frame: Week 1 to Week 48
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the First and Second Infusion)
Time frame: Week 1 to Week 12
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Second and Third Infusion)
Time frame: Week 13 to Week 24
cCH Remission: Number of Participants With No Cluster Headache Attacks For ≥1 Month (>=4 Consecutive Weeks Between the Third and Fourth Infusion)
Time frame: Week 25 to Week 36
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)
Time frame: Week 37 to Week 48
Number of Participants Who Received a Transitional Therapy During the Treatment Period
Time frame: Week 1 to Week 48
Patient Global Impression of Change (PGIC) Score
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48
Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time
Time frame: Baseline (Week 0), Weeks 4, 12, 16, 24, 28, 36, 40, 48
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, 48
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 4, 16, 28, 40 and 48
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
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, 48
Health Care Resource Utilization - Number of Visits to a Family Doctor/General Practitioner
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Visits to a Specialist
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Emergency Department Visits Due to Cluster Headache
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Number of Hospital Admissions Due to Cluster Headache
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Health Care Resource Utilization - Total Number of Overnight Hospital Stays Due to Cluster Headache
Time frame: Baseline (Week 0), Weeks 4, 16, 28, 40, 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40252664Tassorelli C, Jensen RH, Goadsby PJ, Charles AC, Tepper SJ, Snoer AH, Josiassen MK, Linander CB, Ettrup A, Sperling B, Boneva N. Long-term safety, tolerability, and efficacy of eptinezumab in chronic cluster headache (CHRONICLE): an open-label safety trial. Lancet Neurol. 2025 May;24(5):429-440. doi: 10.1016/S1474-4422(25)00065-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eptinezumab in people with Chronic Cluster Headache, run by H. Lundbeck A/S at 31 sites in 9 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 4 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 6 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 31 sites in France, United States, Italy, Spain, Denmark and 4 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 6 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?
Number of Participants With Treatment-emergent Adverse Events (AEs) (time frame: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56). 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 NCT05064397, 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 6 Aug 2024.