RecruitingPHASE3INTERVENTIONAL

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

This research is about finding a better treatment for chronic cluster headaches, which are severe, one-sided head pains that happen often. When usual medicines aren't enough, we're exploring if a precise injection of botulinum toxin (like Botox) can help. This medicine is aimed at a specific nerve area deep in the face, called the sphenopalatine ganglion (SPG), which plays a role in these headaches. Past smaller studies showed this might be safe and helpful. This larger study is comparing the treatment to a dummy injection (placebo) to see if it truly reduces how often and how badly people get these cluster headache attacks.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Norwegian University of Science and Technology

Enrolment target

112

Start

01 Nov 2019

Estimated completion

01 Sep 2025

Cluster Headache

What is this study about?

Imagine getting very intense, one-sided headaches, often behind your eye, that come in waves or 'clusters.' These are called cluster headaches, and for some people, they happen all the time, making life very difficult. While there are treatments, they don't always work well for everyone, or they might cause too many side effects.

This study is trying a new approach. There's a special nerve 'switchboard' deep inside your face, behind your nose, called the sphenopalatine ganglion (that's a mouthful, so let's call it the SPG). This SPG is thought to play a big part in causing cluster headache pain. Scientists have found ways to target this area with medicine.

We're testing if injecting a tiny amount of a medicine similar to Botox (botulinum toxin type A) very precisely near this SPG can help reduce how often people get these painful cluster headaches. This particular study is a 'Phase 3' trial, which means it's a larger study designed to confirm if the treatment is effective and safe before it can be widely used. Participants will get either the actual medicine or a dummy injection (placebo), and neither they nor their doctors will know which one they’ve received until the study is over. This helps us get very clear results about whether the treatment truly works.

Key takeaways

This study is for people with frequent, severe cluster headaches that don't respond well to other treatments.
It's testing a new approach using a single, precise injection of botulinum toxin (Botox-like medicine) near a specific nerve in the face.
You might receive the active medicine or a 'dummy' injection (placebo).
Participation involves keeping your current medications, tracking headaches, and attending follow-up appointments.
The aim is to see if this treatment can reduce how often severe cluster headache attacks happen.

Who may be eligible?

To join this study, you must be between 18 and 85 years old and have chronic cluster headaches. This means your headaches must fit specific characteristics and happen very frequently — at least four times a week on one side of your head over several months.

Critically, your current treatments for cluster headaches must not be working well enough, or you might have had bad side effects from them. You should be able to tell the difference between your cluster headaches and any other types of headaches you might have. If you're a woman who could get pregnant, you'll need to use very effective contraception for a period after the injection.

You cannot join if you've recently changed your headache medications or if you're using certain nerve stimulation devices that aren't stable. Also, if you've had certain nerve-blocking treatments for your headaches that didn't work (like oxygen or triptans), or if you've been in another similar drug study recently, you might not be able to participate.

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 my cluster headaches happening very often (at least 4 times a week) and on one side?
Do my current treatments for cluster headaches not work well for me, or do they cause bad side effects?
Am I between 18 and 85 years old?
Am I able to understand and follow study instructions, including using effective birth control if I'm a woman who could get pregnant?
Have I avoided making major changes to my headache prevention medicines recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some checks to make sure the study is right for you. You'll then receive a single injection of either the study medicine (botulinum toxin type A) or a dummy treatment (placebo) near the sphenopalatine ganglion in your face. This will be done using a special guiding system to ensure it's very precise. You, your study doctor, and the research team won't know whether you received the actual medicine or the placebo – this is to make the study fair and accurate.

Throughout the study, you'll be asked to keep taking your usual preventative headache medicines without changing their dose or type. You'll also need to regularly record your headache attacks. There will be several follow-up visits or checks to see how you're doing, track your headaches, and monitor for any side effects. The total duration of your participation will involve these checks and regular reporting.

Potential risks and benefits

Participating in this study might offer some potential benefits, as it's testing a new approach that could reduce the frequency of your severe cluster headaches if other treatments haven't helped. However, there's also a chance you might receive a placebo, meaning you wouldn't get the active medicine. As with any medical procedure, there are potential risks associated with the injection, such as discomfort, bruising, or other rare side effects in the area where the injection is given, or from the medicine itself. The research team will explain all known risks to you in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

Praxisklinik Ulmenhof
Verified postcode
Hamburg, Germany· Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta (CBNI)
Verified postcode
Milan, Italy· Recruiting
St Olavs Hospital
Verified postcode
Trondheim, Norway· Recruiting
Department of Neurology, University Clinic Hospital. Catholic University of Valencia
Verified postcode
Valencia, Spain· Recruiting
National Hospital of Neurology and Neurosurgery, University College of London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'cluster headache'?

Cluster headaches are very severe, one-sided head pains that usually occur around the eye or temple. They come in 'clusters' or periods of frequent attacks, and can be extremely disabling.

What is botulinum toxin type A?

It's a medicine often known as 'Botox' that temporarily relaxes muscles or affects nerve signals. In this study, it's being explored for its ability to calm specific nerve activity linked to headaches.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers fairly compare if the new medicine really works better than no treatment.

Why is it important that neither I nor my doctor know what I'm receiving?

This is called 'blinding' and it's a standard and important part of good research. It ensures that expectations don't accidentally influence how people describe their symptoms or how doctors assess them, making the results more reliable.

What is the 'sphenopalatine ganglion'?

It's a small bundle of nerves (like a 'switchboard') located deep in your face, behind your nose. It's thought to play a key role in transmitting pain signals for cluster headaches.

How to find out more

Tore Wergeland Meisingset, md phd

tore.w.meisingset@ntnu.no +47 728 21 335 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.