A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinso… (NCT07157735) | Clinical Trial Compass
RecruitingPhase 2
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
United Kingdom36 participantsStarted 2026-02-02
Plain-language summary
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.
Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.
The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:
1. is dapansutrile safe and well-tolerated in people with Parkinson's?
2. does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial.
Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.
Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be included in the trial, the potential participant must:
* Have given written informed consent to participate.
* Be aged between 50 and 80 years (inclusive) at the time of the screening visit.
* Be a fluent English speaker.
* Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease.
* Have a disease duration of less than 5 years at the time of screening visit.
* Have early-stage PD, defined as Hoehn and Yahr stage ≤2.
* Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline.
* Have hsCRP ≥ 1 mg/L on a blood test done within 2 years prior to, or at, the screening visit.
* Have adequate organ function, as defined below (to be rechecked prior to baseline/investigational medicinal product \[IMP\] initiation if \>42 days from screening visit): Haemoglobin ≥ 110 g/L; Platelet count ≥ 130 × 109/L; Neutrophil count ≥ 1.5 × 109/L; Renal function: estimated glomerular filtration rate (eGFR) \>45 mL/min/1.73m2; Hepatic function: alanine aminotransferase (ALT) and bilirubin \< 1.5 times the institutional upper limit of normal; Thyroid function: thyroid stimulating hormone (TSH) within normal range; or if TSH is abnormal, free T4 within normal range; Corrected calcium ≤ institutional upper limit of normal; Alkaline phosphatase (ALP) \< 1.5 times the institutional upper…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial and the main thing being measured is how many adverse events occur over 6 months, what does that mean about how much is still unknown regarding whether dapansutrile is safe or effective for Parkinson's disease?
2Dapansutrile is described as an anti-inflammatory medication — can you explain what role inflammation is thought to play in my Parkinson's disease, and whether that makes me a candidate who might benefit from this approach?
3The trial involves a 6-month double-blind period, meaning I might receive a placebo instead of the actual drug — how would that affect my current Parkinson's treatment, and would I still be able to take my existing medications?
4Are there standard Parkinson's treatments or other studies I should consider before exploring this trial, given that it's still in the phase of gathering safety data?
5What would the monitoring and follow-up schedule look like during those 6 months, and is that level of commitment realistic given my current health and daily situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events (AEs) recorded during the 6-month double-blind period
Timeframe: Assessed at screening, baseline, day 1, and weeks 2, 4, 6, 12, 18, 23 and 26.
Trial details
NCT IDNCT07157735
SponsorCambridge University Hospitals NHS Foundation Trust