Episodic cluster headache Episodic Cluster Headache
Conditions
Interventions
Patients will have a 1:1 chance of receiving eptinezumab or placebo at the
first infusion visit (Baseline Visit/Visit 3). At the end of the
Placebo-controlled Period (end week 4), all patients will
Sponsors
Lundbeck
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - The patient has episodic cluster headache, as defined by IHS ICHD-3 classification, with an adequately documented record or reliable 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, when untreated. - 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. In the opinion of the investigator the cluster headache bout is likely to continue for at least another 6 weeks based on prior cluster period history. Under exceptional circumstances, when a patient is able to attend Screening Visit 2 only during the second week after the first typical cluster headache attack, the possibility to enroll this patient in the study will be discussed with the investigator and the decision will be taken in the context of known history of typical duration of the bout for the individual patient. - The patient has during Screening Period 2 based on prospectively collected information in the eDiary a weekly cluster headache attack frequency of a (this requirement should not be shared with the patient): a. minimum of at least 7 total cluster headache attacks out of the 7-day Screening Period 2 b. maximum of 56 cluster headache attacks out of the 7-day Screening Period 2 - The patient has an adequately documented record or reliable history of previous acute and preventive medication use for eCH, for at least 12 months prior to Screening Visit 1. - The patient has demonstrated compliance with the eDiary by entry of data for at least 6 of the 7 days of Screening Period 2. - The patient has had a medical history of cluster headache from =18 and
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 |
|---|---|
| Primary endpoint: - Change from baseline in number of weekly attacks (Weeks 1-2) Key secondary endpoints: - Response: 50% reduction in number of weekly attacks (Weeks 1-2) - Change from baseline in weekly number of times an abortive therapy was used (Weeks 1-2) - Change from baseline in the number of daily attacks (Days 1-3) - Change from baseline in weekly number of days with less than 3 attacks per day (Weeks 1-2) - Time to resolution of cluster headache bout within 4 weeks after the first IMP infusion - Number of attacks starting within 24 hours of the start of the first infusion - Change from baseline in the daily mean score on 5-point self-rating pain severity scale (Days 1- 3) - Change from baseline to Week 1 in number of attacks - Change from baseline to Week 2 in number of attacks - Response: 50% reduction in number of attacks in Week 1 - Response: 30% reduction in number of attacks in Week 1 - Response: 30% reduction in number of weekly attacks (Weeks 1-2) - 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. - 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. - 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. - Change from baseline in the number of weekly attacks (Weeks 1-4) - 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. - | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in EQ-5D-5L at Weeks 2 and 4 - Health Care Resources Utilization (HCRU) at Week 4 - Change from baseline in the Work Productivity Activity Questionnaire: General Health second version (WPAI:GH2.0) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment) at Week 4 | — |
Countries
Netherlands
Outcome results
None listed