Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start study to evaluate the efficacy and safety of eptinezumab in patients with episodic Cluster Headache

H. Lundbeck A/S0 个研究点目标入组 304 人开始时间: 2020年12月22日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•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, 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.
•The patient has 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

•The patient has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway (anti-CGRP mAbs and
•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).

发起方