A study to evaluate the efficacy and safety of eptinezumab in patients with episodic cluster headache

Phase 1

• Conditions: Episodic cluster headache; MedDRA version: 24.0Level: PTClassification code 10059133Term: Cluster headacheSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-001969-37-CZ
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 304

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 <=50 years of age.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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