Episodic 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 patient has episodic cluster headache, as defined by IHS ICHD-3 classification, with a documented history of eCH of at least 12 months prior to Screening Visit 1. • The patient has a prior history of cluster period(s) lasting 6 weeks or longer. • The patient is able to distinguish cluster headache attacks from other headaches (i.e. tension-type headaches, migraine). • The patient 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 patient has had a medical history of cluster headache from =65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: • The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP mAbs and gepants). • The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, complex regional pain syndrome). • The patient 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). • Patients with a lifetime history of psychosis, bipolar mania, or dementia are excluded. Patients 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 patient is, at Screening Visit 2, at significant risk of suicide. • The patient 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy of eptinezumab in patients with episodic Cluster Headache (eCH);Secondary Objective: To evaluate the efficacy of eptinezumab on health-related quality of life, health care resource utilization, and work productivity;Primary end point(s): 1. Change from baseline in number of weekly attacks;Timepoint(s) of evaluation of this end point: 1. Weeks 1-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Response: >= 50% reduction in number of weekly attacks 3. Change from baseline in weekly number of times an abortive therapy was used 4. Change from baseline in the number of daily attacks 5. Change from baseline in weekly number of days with less than 3 attacks per day 6. Time to resolution of cluster headache bout within 4 weeks after the first Investigational Medicinal Product (IMP) infusion 7. Number of attacks starting within 24 hours of the start of the first infusion 8. Change from baseline in the daily mean score on 5-point self-rating pain severity scale 9. Change from baseline to Week 1 in number of attacks 10. Change from baseline to Week 2 in number of attacks 11. Response: >= 50% reduction in number of attacks in Week 1 12. Response: >= 30% reduction in number of attacks in Week 1 13. Response: >= 30% reduction in number of weekly attacks (Weeks 1-2) 14. Change from baseline in weekly integrated measure of frequency and intensity of pain (Weeks 1-2): For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week 15. Change from baseline to Week 1 in integrated measure of frequency and intensity of pain: For Week 1 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week 16. Change from baseline to Week 2 in weekly integrated measure of frequency and intensity of pain: For Week 2 add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week 17. Change from baseline in the number of weekly attacks 18. Change from baseline in weekly integrated measure of frequency and intensity of pain (Weeks 1-4). For each week add the intensity (worst pain on 5-point self-rating pain severity scale) for each attack experienced during that week for each attack experienced during that week. 19. Change from baseline in the mean score on 5-point selfrating pain s | — |
Countries
Belgium, Czechia, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Italy, Netherlands, Norway, Portugal, Russian Federation, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactLundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
Outcome results
None listed