Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

(REGON) Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headache

This study is investigating if repeated injections around a nerve called the Greater Occipital Nerve (GON), located at the back of the head, can help prevent future attacks in people who suffer from chronic cluster headaches. Cluster headaches are very painful and happen in cycles. Researchers want to see if the injections, which contain a type of medicine, can reduce how often and how severely these headaches occur. They will compare a number of patients receiving the active medicine with others receiving a dummy injection (placebo) to understand if the real medicine is effective and how long its effects last. This is a "Phase III" trial, meaning it's one of the final steps before a treatment might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

09 Aug 2024

Cluster headache

What is this study about?

Imagine having incredibly painful headaches that come in clusters, sometimes daily, and disrupt your life significantly. This study is for people who experience these severe "cluster headaches" on an ongoing basis. It's looking into a new way to prevent them from happening so often, or to make them less severe when they do occur.

The treatment being tested involves injections given around a specific nerve at the back of your head, called the Greater Occipital Nerve. The injections contain a type of medicine known as a corticosteroid, which helps reduce inflammation and can ease pain. The aim is to see if regular, repeated injections can act as a kind of preventative shield against cluster headaches.

To really understand if this treatment works, the study will compare people who receive these corticosteroid injections with others who receive a 'dummy' injection, which looks exactly the same but doesn't contain the active medicine (this is called a placebo). This comparison helps researchers be sure that any positive effects they see are truly due to the medicine and not just other factors. The main thing they want to find out is how long people can go without their usual headache pattern after starting the injections. This is an important step in researching new ways to help those living with chronic cluster headaches.

Key takeaways

This study evaluates injections for chronic cluster headaches.
It tests a steroid medicine against a dummy injection.
The main goal is to see how long people stay free from headache patterns.
Participation involves regular injections and tracking headache data.
Suitable for adults (18+) with ongoing cluster headaches.

Who may be eligible?

To take part in this study, you would need to be an adult, aged 18 or older. Both men and women are welcome.

The most important thing is that you have been officially diagnosed with chronic cluster headaches. This means your headaches are happening regularly and have been a long-term problem for you.

There might be other specific health requirements or conditions that could mean you can't take part. These are put in place to ensure your safety and that the study results are as clear as possible. The medical team running the study will check if you meet all the necessary criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with chronic cluster headaches?
Are you able to attend regular appointments for injections and check-ups?
Are you generally willing to track your headache frequency and severity?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive regular injections around a nerve at the back of your head. These injections will either contain the study medicine or a dummy solution; neither you nor your doctor will know which you are getting. You'll have scheduled appointments to receive these injections and for check-ups.

Throughout the study, you'll be asked to keep track of your headaches – how often they happen, how severe they are, and if you need any other medication to relieve them. You might also fill out questionnaires about your quality of life. The study will monitor how long the effects of the injections last. The total duration of your participation, including follow-up, will be determined by the study design, and the number of injections you receive will depend on how you respond to the treatment.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a treatment that might help reduce your cluster headache attacks or their severity. You will also be closely monitored by a medical team. However, there are potential risks, like side effects from the injections (e.g., pain, bruising at the injection site, or more rarely, nerve irritation from the corticosteroid) or the possibility of receiving the dummy treatment, which would not directly help your headaches. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is a cluster headache?

Cluster headaches are very severe headaches that happen in patterns, or 'clusters.' They are often felt around one eye and can be incredibly painful.

What is the Greater Occipital Nerve?

It's a nerve located at the back of your head that supplies feeling to the scalp. Injections around this nerve are sometimes used to treat certain types of headaches.

What does 'Phase III' mean for this study?

Phase III means this is one of the final stages of testing a new treatment. It usually involves a larger number of people to confirm how well the treatment works and its safety before it can be widely used.

Will I know if I'm getting the real medicine or the dummy injection?

No, this is a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving the active medicine or the placebo. This helps make the study results more accurate.

How long will I be in the study?

The study aims to see how long the effects of the treatment last, so the total duration will vary depending on your individual response and the study's design. You will be informed of estimated timelines.