Status:
COMPLETED
Eptinezumab in Participants With Episodic Cluster Headache
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Cluster Headache, Episodic
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)
Detailed Description
Eligible participants will be randomly assigned to receive treatment, in a blinded manner, two infusions of either eptinezumab or placebo in a cross-over manner during the Placebo-controlled Period an...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- The participant has episodic cluster headache, as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) classification, with an adequately documented record or reliable history of eCH of at least 12 months prior to Screening Visit 1.
- The participant has a prior history of cluster period(s) lasting 6 weeks or longer, when untreated.
- The participant is able to distinguish cluster headache attacks from other headaches (that is; tension-type headaches, migraine).
- The participant 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 participant has a medical history of first symptoms of cluster headache from ≤60 years of age.
- 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 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).
- Participants with a lifetime history of psychosis, bipolar mania, or dementia are excluded. 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 2 are also excluded.
- The participant is, at Screening Visit 2, at significant risk of suicide.
- The participant 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).
- Other inclusion and exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04688775
Start Date
December 23 2020
End Date
October 5 2023
Last Update
August 9 2024
Active Locations (120)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Mayo Clinic in Arizona - Phoenix Campus
Phoenix, Arizona, United States, 85054
3
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
4
Clinical Research Institute
Los Angeles, California, United States, 90048