Chronic cluster headache MedDRA version: 24.0 Level: PT Classification code 10059133 Term: Cluster headache System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion 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 had a diagnosis of cluster headache at =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main goal of this trial is to inform about long-term safety and tolerability of eptinezumab in participants with chronic cluster headache.;Secondary Objective: To evaluate the efficacy of eptinezumab in patients with cCH;Primary end point(s): Number of Participants With Adverse Events;Timepoint(s) of evaluation of this end point: From the day of first dose of study drug (Baseline [Week 0]) up to Week 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 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) 2. 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 3. Change From Baseline in the Average Number of Weekly Attacks, Averaged Over the First 4 Weeks After Each Infusion 4. Change From Baseline in the 5-Point Self-Rating Pain Severity Scale, Averaged Over the First 4 Weeks After Each Infusion 5. Response: Number of Participants With =30% Reduction From Baseline in Number of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion 6. Response: Number of Participants With =50% Reduction From Baseline inNumber of Weekly Attacks Averaged Over the First 4 Weeks After Each Infusion 7. cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks) 8. cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the First and Second Infusion) 9. cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the Second and Third Infusion) 10. cCH Remission: Number of Participants With No Cluster Headache Attacks For =1 Month (5 Consecutive Weeks Between the Third and Fourth Infusion) 11. 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) 12. Number of Participants who Received a Transitional Therapy During the Treatment Period 13. Patient Global Impression of Change (PGIC) Score 14. Change From Baseline in Sleep Impact Scale (SIS) Domain Scores Over the Time 15. Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Score at Weeks 4, 16, 28, 40 and 48 16. Health Care Resources Utilization (HCRU) Score 1 | — |
Countries
Denmark, Finland, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed