Eptinezumab in patients with episodic Cluster Headache
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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
You are being asked to take part in this research study because you have been diagnosed with episodic Cluster Headache. Episodic Cluster Headache is a rare but disabling headache disorder characterised by episodic attacks of intense unilateral headache (pain in one half of your head only), frequently associated with symptoms such as production of tears, redness of the eye, and a stuffy nose. The natural course of episodic Cluster Headache consists of two phases: (1) cluster periods, also called “bouts” (typically lasting weeks or months) composed of a series of 15-180 minute attacks of severe (often excruciating) headache, occurring near-daily to multiple times per day, and (2) attack-free periods that may last for weeks, months, or even years.
The purpose of this study is to determine if the study medication, eptinezumab, is safe and effective as treatment for those who suffer from episodic Cluster Headache. Eptinezumab is a humanised monoclonal antibody (a type of antibody made in the laboratory). Eptinezumab has previously been tested in animals, healthy volunteers and also adults with a diagnosis of migraine and is approved by the US Food and Drug Administration (FDA) as a preventive treatment for migraine. Eptinezumab works by blocking a small protein produced by neurons, called CGRP (calcitonin gene-related peptide), which is involved with Cluster Headache, as well as migraine. Eptinezumab has been associated with pain relief in patients with migraine, and it is believed to have the potential to reduce the number of cluster headache attacks in patients with episodic Cluster Headache. The main questions the researchers want to answer are:
- Does eptinezumab help the participants’ episodic Cluster Headache symptoms?
- Is eptinezumab well tolerated and safe for participants with episodic Cluster Headache?