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Contact Information:

Dr Caroline Williams-Gray
+44 (0)1223 767069
cuh.dapa-pd.trial@nhs.net


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Be Part of Research - Trial Details - DAPA-PD: a trial to test the use of dapansutrile, an anti-inflammatory medication, in people with Parkinson’s disease
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DAPA-PD: a trial to test the use of dapansutrile, an anti-inflammatory medication, in people with Parkinson’s disease

Recruiting

Open to: All Genders

Age: Mixed

Cambridge

Medical Conditions

Parkinson's disease

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


In Parkinson’s disease, an area of the brain called the substantia nigra, loses nerve cells (called neurons) which produce a chemical called dopamine. Dopamine plays a vital role in regulating the movement of the body, and a reduction of dopamine is responsible for many of the symptoms of Parkinson’s disease. Research has suggested that inflammation in the brain may contribute to this loss of nerve cells.
We want to find out whether using a medication called dapansutrile can reduce inflammation in the brain in people with Parkinson’s, and whether it has an impact on the progression of Parkinson’s disease.
Dapansutrile is a medication which acts by suppressing inflammation. Dapansutrile is not yet licensed, which means it is not approved for use in any disease area or in any country. However, it has been used in clinical trials, including in people with heart failure, acute gout, COVID-19, and melanoma. In these trials, dapansutrile has been shown to be safe for use in people.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2025 31 Mar 2026

There are two main parts of the study:
1. Randomised, placebo-controlled phase: where two-thirds of the participants will receive dapansutrile and a third will receive a ‘dummy drug’ called a placebo for 26 weeks. Neither the participant nor the trial doctor will know which treatment is being taken, although the trial doctor can find out if necessary.
2. Optional open-label phase: where all participants who agree to take part in this section will receive dapansutrile for an additional 26 weeks (whether or not they have received dapansutrile in the first part).
The trial is being conducted in Cambridge. Participants will need to attend 10 in-person visits during the randomised, placebo-controlled phase. If the participant does not wish to continue to the optional open-label phase, they will attend one final in-person visit. If they do agree to take part in the open-label phase, they will attend an additional 7 visits during the open-label phase.


Patients aged 50 to 80 years (inclusive) with early Parkinson's disease

You can take part if:



You may not be able to take part if:


1. Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.2. Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline.3. Any previous use of rituximab or alemtuzumab at any time.4. Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline.5. Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) – including aspirin >75 mg, naproxen, ibuprofen and meloxicam – on more than 2 days per week.6. Known inflammatory or autoimmune disease.7. Chronic or latent infection.8. Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline.9. Skin, solid organ or haematological malignancy within the 5 years prior to screening visit, or between screening and baseline.10. The inability to take or swallow oral medication.11. Parkinson’s Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria.12. A known genetic mutation associated with PD.13. A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV) or syphilis.14. Chronic liver disease.15. Any concurrent medical or psychiatric condition or disease that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial.16. Women of childbearing potential – female participants must be surgically sterile or be post-menopausal. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.17. Male participants must be surgically sterile or must agree to use effective contraception (as specified in the trial protocol) during the period of therapy and for 6 months after the last dose of the trial treatment.18. Known hypersensitivity to dapansutrile or its excipients.19. Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another interventional investigational trial. Participants currently enrolled in other observational studies may be recruited.20. Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes.21. Concomitant treatment with any medications that could interfere with [18F]-DPA714 binding (e.g., benzodiazepines).22. Current use of any drugs of abuse or average alcohol intake of >21 units per week over the last 3 months.23. Any other significant disease, disability or investigation result which, in the opinion of the Chief Investigator (CI), may either put the participant at risk, or may influence the result of the trial, or the participant’s ability to participate in the trial.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbrookes
    Addenbrookes Hospital Hills Road
    Cambridge
    CB2 0QQ

There is no guarantee that there will be any direct benefits for the participants. Based on previous research, the researchers believe that anti-inflammatory medications might have benefits in early Parkinson's. It is possible that participants may experience relief in their Parkinson's symptoms or an improvement in their disease, but the effects of the trial medication are currently unknown. Taking part in the study will contribute to medical knowledge and information collected as part of the trial may significantly benefit people with Parkinson's disease in the future.
As with all medications, dapansutrile has the potential to cause side effects. However, as it is still a relatively new medication, we can’t yet be clear which side effects we can expect. In clinical trials to date, dapansutrile has been well tolerated with no serious reactions attributed to the medication.
There is a substantial time commitment associated with being part of a trial. We have minimised visits as much as possible to help with this.
Blood tests can cause minor discomfort and bruising of the skin. Standard protocols will be followed to reduce these risks, and to prevent infections. None of the blood tests in the trial will be fasting blood tests.
PET scans use a radioactive liquid (tracer) which is injected into the body to label certain cells in the brain so that we can see them on the scan. The tracer has short-lived radioactivity and there are no precautions for participants to take after the scan has been carried out. Like all medicines, injected tracers can be associated with some side effects. Side effects are rare and often relatively minor and short-lived but can include nausea, rash, abdominal discomfort, cold flushes and dizziness. Severe reactions are possible but are very rare and have never occurred in any of our own studies.
The PET scan uses ionising radiation to form images of the brain. Ionising radiation may cause cancer many years or decades after the exposure. We are all at risk of developing cancer during our lifetime. 50% of the population is likely to develop one of the many forms of cancer at some stage during their lifetime. Taking part in this trial will increase the chances of this happening from 50% to about 50.02%.
MRI scans involve a large magnet which is used to create high-quality pictures of the internal organs. Any metallic implants in the body will prevent a potential participant from taking part in this type of scan. We will go through a checklist to ask whether the participant has metal objects attached to or inside their body (e.g. stents, shrapnel, plated fractures, piercings, tattoos) or electronic devices (e.g. heart pacemaker). Many such items (most modern cardiac stents, for instance) are designed to be MRI-safe.
Participants will be asked to lie as still as they can in a small and enclosed space in the scanner for up to 90 minutes. Some participants may find this claustrophobic. The scanner is noisy, but participants will be given earplugs and/or headphones. Some patients might feel a bit dizzy or have a metallic taste in their mouth as they enter the scanner, but this will pass and we will be careful to make the scan as comfortable as possible. The technician performing the MRI scan will communicate with the participant throughout the scan to check that they remain comfortable. If needed, the scan can be stopped at any point.
There is a chance that scans may show a significant abnormality of which the participant is unaware. Similarly, in some cases blood tests, ECGs or our assessments may discover something about the participant's health that they are unaware of. In such circumstances, we would discuss the findings with the participant and inform their GP. If referral to another specialist was required, we would arrange this, in consultation with their GP, if that is what they would like. Such early detection of new medical issues has the benefit of starting treatment early but, in a small number of cases, may have implications for future employment and insurance.
A possible side effect of a lumbar puncture is a headache, usually coming on within about 48 hours. Post-lumbar puncture headaches have been reported to occur in up to 1 in 4 people, but more recent studies using modern methods show much lower rates, of around 1 in 20 people. The risk may be reduced by drinking plenty of fluids (a litre of water a day until the following day). If a headache does develop, it usually responds well to resting in bed, paracetamol and caffeine-containing drinks. For the lumbar puncture itself, we use local anaesthetic, but there may still be a feeling of pressure in the lower back at the time of the procedure, or mild tenderness or pain afterwards, which settles after a short time. Occasionally, there may be a little bleeding from the puncture site, as sometimes happens after a routine blood sample is taken. Rarely, some bruising or swelling at the site may occur. Serious complications after a lumbar puncture are extremely rare. These rare complications include tingling and numbness in the legs, infection in the spine, double vision, tinnitus and hypersensitivity to light or sound, but these are so rare as to be unquantifiable.
All risks are outlined in the participant information sheet and discussed with the participant as part of the consent process.

Dr Caroline Williams-Gray
+44 (0)1223 767069
cuh.dapa-pd.trial@nhs.net



The study is sponsored by Cambridge Clinical Trials Unit and funded by Cure Parkinson's Trust.




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Read full details for Trial ID: ISRCTN16806940
Last updated 09 May 2025

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