Eptinezumab in Participants With Episodic Cluster Headache (ALLEVIATE)

  • STATUS
    Recruiting
  • End date
    Jul 3, 2023
  • participants needed
    304
  • sponsor
    H. Lundbeck A/S
Updated on 27 July 2022

Summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

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 and Active Treatment Period of the study.

The total duration of the study after randomization is 24 weeks, including a safety follow-up period of 8 weeks.

Details
Condition Cluster Headache, Episodic
Treatment Placebo, Eptinezumab
Clinical Study IdentifierNCT04688775
SponsorH. Lundbeck A/S
Last Modified on27 July 2022

Eligibility

Yes No Not Sure

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 a documented 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 ≤50 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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