Cluster Headache Clinical Trials 2022

What are Cluster Headaches Clinical Trials?

Cluster headaches are a serious neurological issue in the form of severe headaches, generally on one side of the head near the eyes. Other symptoms include nasal congestion, light sensitivity, eye-watering and swelling. These headaches cluster together, meaning they come and go in spells one after another, lasting anywhere from 15 minutes to 3 hours.

There are two types of cluster headaches, episodic and chronic. Episodic cluster headaches happen from seven days to a year and go into remission for approximately three months before starting again. Chronic ones last for more than a year.

The pain from a cluster headache is more severe than a migraine. It is often described as intense drilling, squeezing, or stabbing sensation. The frequency and severity of these headache attacks can seriously affect a person's mental health. Research has found that many people who suffer from cluster headaches have a poor quality of life and are more likely to have depression and suicidal thoughts.

Why Study Cluster Headaches Through Clinical Trials?

It is believed that 1 in 1000 people suffer from cluster headaches. This accounts for just 0.1% of the US population, making it a challenging condition to study as the sample sizes are so small. While researchers understand the role of the facial and trigeminal nerves in cluster headaches, they still don't know what causes these nerves to be overactive. Thus there is no long-term cure currently available.

This is why clinical trials are necessary. They help identify possible causes and risk factors that ultimately lead to the development of therapies. This can manage the severity and frequency of the headaches, drastically improving a person’s quality of life.

What Are The Types of Treatments Available For Cluster Headaches?

Several management techniques for cluster headaches are used to help prevent and reduce the intensity of the symptoms. Medications such as verapamil, a calcium channel blocker, and lithium are given as long-term solutions to reduce attacks. These are often given with glucocorticoids (short-term medication) to help reduce recurrence, especially in people with chronic cluster headaches.

Oxygen therapy is also used to reduce the time of a cluster headache attack. This is done by administering 12 – 15 liters per minute for 20 minutes. While it helps improve conditions for 70% of patients within 10 – 15 minutes, it does not prevent future attacks.

People with cluster headaches also try alternative therapies such as electrotherapy, homeopathy, acupuncture, or botulinum toxin injections, but there is little evidence that these work to prevent attacks.

Surgical procedures, such as occipital nerve stimulation and deep brain stimulation, have been shown to help in some cases. However, it takes months before the effects are felt.

What are Some Notable Breakthroughs in Cluster Headaches Clinical Trials?

2014: A treatment study sponsored by ElectroCore Inc found that their non-invasive device, the GammaCore, was effective in stimulating the vagus nerve in the neck. This nerve connects to the brain stem's pain system and, in the trial, reduced the pain intensity from a cluster headache.

2019: Research has shown that the drug galcanezumab, which is used for migraines, is an effective management option for cluster headaches. This injected medication was given monthly and essentially shortened the frequency of cluster headaches in 70% of cases. It has since been FDA-approved.