Eptinezumab in Participants With Episodic Cluster Headache (ALLEVIATE)

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Cluster Headache, Episodic

Treatments: Drug: Placebo; Drug: Eptinezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04688775

19386A

Details and patient eligibility

About

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

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 2 patient groups

Sequence 1: Eptinezumab Then Placebo

Experimental group

Description:

Eptinezumab in the Placebo-controlled Period, followed by administration of placebo in the Active Treatment Period

Treatment:

Drug: Eptinezumab

Drug: Placebo

Sequence 2: Placebo Then Eptinezumab

Experimental group

Description:

Placebo in the Placebo-controlled Period, followed by administration of eptinezumab in the Active Treatment Period

Treatment:

Drug: Eptinezumab

Drug: Placebo