CLE-500 is being developed as a patient-controlled drug-device combination for the immediate relief of cluster headaches. The device we are developing is easy to use and conveniently portable for the patient to use wherever and whenever headaches occur.
CLE-500 is a new investigational drug-device combination that has not been approved for commercial distribution.
Cluster Headache is a neurological disorder characterized by recurrent severe headaches on one side of the head, typically around the eye. It is three times more prevalent in men and its onset is usually between the ages of 20–40. Cluster Headaches affect about 0.1% of people worldwide and is often referred to as the “most severe pain known to man”.
Each cluster headache attack typically lasts between 15–180 minutes. They usually occur with clocklike regularity: most sufferers have one to three attacks per day, although some have up to eight attacks daily. A bout of regular attacks, known as a cluster bout, can last weeks to months.
There is no cure for Cluster Headaches and patients currently have limited treatment options to prevent or stop attacks.
I didn’t understand what was happening during my first attack. The pain reached an intensity that I had never felt before. Nothing in my life mattered to me in that moment and I regretted being born
I have trouble functioning and I am scared to go to sleep at night. I know that I will be woken up with intense pain. The lack of sleep makes it hard for me to concentrate and makes me terribly irritable
The effect that this has on my relationships is one of the hardest parts. When I am in a cluster cycle, I am moody, short-tempered, and exhausted. I shut people out of my life. Even though my loved ones mean well, I feel like they don’t really understand me
CLE-500 is an intranasal drug-device combination that targets a specific nerve pathway at the sphenopalatine ganglion, a ganglion associated with Cluster Headache attacks. By blocking this nerve pathway, we aim to provide pain relief within 15 minutes.
The sphenopalatine ganglion (SPG) is an extracranial parasympathetic nerve ganglion that is activated by the trigeminal-autonomic reflex and is thought to largely contribute to the autonomic symptoms of Cluster Headache, such as tearing and nasal congestion. Neural modulation of the SPG has been performed for over 100 years (Sluder G, 1908) through a variety of techniques and has been shown to reduce Cluster Headache pain.
Clexio is developing a device that aims to achieve precise delivery of a proprietary formulation to the SPG. Precise delivery of the formulation has been demonstrated in a variety of in-vitro and ex-vivo models.
We aim for the device to be easy to use so that the patient can self-administer the treatment. So far, we have completed 3 Human Factor studies in Cluster Headache patients to get feedback from patients on the device prototypes and the ease-of-use, and to make sure that the device is developed to best fit patient needs.