RecruitingPHASE2INTERVENTIONAL

A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease

This study is looking into a new medication called dapansutrile for people with Parkinson's disease. We know that inflammation in the brain and body might play a part in how Parkinson's develops and progresses. Dapansutrile is designed to specifically target this inflammation. In this trial, researchers want to find out two main things: first, if dapansutrile is safe and well-tolerated by people with Parkinson's. Second, they want to see if it can reduce inflammation in the brain and in bodily fluids. They will also keep an eye on any changes in Parkinson's symptoms during the study. This research aims to understand if dapansutrile could be a helpful new treatment option in the future.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

Start

02 Feb 2026

Estimated completion

01 Feb 2028

Parkinson Disease

What is this study about?

Parkinson's disease can involve inflammation, not just in the brain, but also in the gut and blood. Scientists believe this inflammation might contribute to how the disease develops and gets worse over time. There's a specific process in the body called the 'inflammasome' that's key to this inflammation, and laboratory studies suggest it might be important in Parkinson's.

Dapansutrile is a new medication that works by targeting this particular inflammasome. Early studies in animals showed that dapansutrile could protect the brain from inflammation and prevent the loss of dopamine cells, which are important for movement. Tests in people so far have suggested that this drug can reduce inflammation effectively without causing serious side effects. This trial builds on that promising work.

So, the main aim of this study is to discover if dapansutrile could be a useful treatment for Parkinson's. Researchers will focus on two key questions: Is dapansutrile safe and does it cause any uncomfortable side effects for people with Parkinson's? And, does dapansutrile actually reduce inflammation in the brain, in the fluid around the brain and spinal cord, and in the blood? They will also be carefully monitoring any changes in Parkinson's symptoms during the trial to see if the medication has a positive impact.

Key takeaways

Tests a new anti-inflammatory drug, dapansutrile, for Parkinson's.
Aims to see if the drug is safe and reduces inflammation.
Involves taking the drug or a placebo for 6 months, then optional active drug for another 6 months.
Requires regular visits, blood tests, brain scans, and lumbar punctures.
For people aged 50-80 with early Parkinson's and signs of inflammation.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for people with Parkinson's disease who are aged between 50 and 80 years old. You would need to have been diagnosed with Parkinson's recently, within the last five years, and be in the early stages of the disease. Importantly, you would also need to show some signs of ongoing inflammation in your body through a blood test.

To be considered, you should be able to speak fluent English and be able to give your full written permission to take part. Your organs, like your kidneys and liver, would need to be working well, and your blood test results should be within a healthy range. You could be taking your usual Parkinson's medications as long as the dose has been steady for at least three months, or you might not be taking any Parkinson's medication yet.

Unfortunately, you wouldn't be able to join if you've taken certain strong immune-system-affecting medications in the last year, or ever taken specific drugs like rituximab. If you've had a brain scan that showed a particular genetic marker linked to inflammation, you also wouldn't be eligible.

Quick self-check

Are you between 50 and 80 years old?
Have you been diagnosed with Parkinson's within the last 5 years?
Are you in the early stages of Parkinson's?
Are you able to speak fluent English?
Are you able to have regular blood tests, brain scans, and lumbar punctures?
Have you *not* taken strong immune-affecting drugs in the last year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll either receive dapansutrile or a placebo, which looks identical but contains no active drug. You won't know which one you're taking, and neither will the study team. You'll take the medication or placebo twice a day, every day, for six months. After these six months, everyone in the study will have the option to take the active dapansutrile for another six months.

Throughout the study, you'll have regular check-ups at the study centre, including blood tests. You'll also need to have a special brain scan before you start treatment and again after about five or six months. In addition, you'll be asked to have a lumbar puncture (a procedure to collect fluid from your spine) at the beginning of the study, after six months of treatment, and a final one after a full year. The total duration of active participation could be up to 12 months, if you choose to continue into the second phase.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as contributing to scientific understanding and possibly gaining access to a new treatment before it's widely available. However, there are also potential risks involved. These could include side effects from the study drug, discomfort from procedures like blood tests, brain scans, or lumbar punctures, and the time commitment required. Remember, you can withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (1)

John Van Geest Centre for Brain Repair
Cambridge, United Kingdom· Recruiting

Common questions

What is inflammation and why does it matter in Parkinson's?

Inflammation is your body's response to injury or infection. In Parkinson's, inflammation in the brain and body might play a role in how the disease progresses.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medication but doesn't contain any active drug. It helps researchers see if the real drug is having an effect beyond what might happen naturally.

Will I know if I'm getting the real drug or the placebo?

No, during the first six months, neither you nor the study team will know if you're taking dapansutrile or the placebo. This helps make the study as fair as possible.

What is a lumbar puncture?

A lumbar puncture is a procedure where a small amount of fluid is taken from your lower back, from around your spinal cord. This fluid can tell us about what's happening in your brain.

What happens after the first six months?

After six months, all participants will have the option to take the active study drug, dapansutrile, for an additional six months.

How to find out more

Trial Coordinator

mcd68@cam.ac.uk 44 1223 331160 Official trial record

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