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New treatment option for Parkinson Disease
Official title A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
ClinicalTrials.gov ID: NCT07157735
What this study is testing
What is dapansutrile?
dapansutrile is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- 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...
You likely can't join if
- The presence of any of the following will preclude inclusion:
- Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within...
- Any previous use of rituximab or alemtuzumab at any time.
- 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...
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days...
See the full eligibility 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 ×...
- The presence of any of the following will preclude inclusion:
- Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- 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.
- Any previous use of rituximab or alemtuzumab at any time.
- 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.
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week.
- Clinically significant inflammatory or autoimmune disease.
- Chronic or latent infection.
- Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline.
- Skin, solid organ or haematological malignancy which is active\ at screening, or between screening and baseline (\ defined as cancer which is under active management, with the exception of low-grade malignancy under...
- The inability to take or swallow oral medication.
- Parkinson's Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria.
- A known genetic mutation associated with PD.
- A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV) or syphilis.
- Chronic liver disease.
- 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...
- 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).
- Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after the last dose of the trial treatment.
- Known hypersensitivity to dapansutrile or its excipients.
- Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another treatment investigational trial. Participants...
- Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes.
- Concomitant treatment with any medications that could interfere with [18F]-DPA714 binding (e.g., certain benzodiazepines), with the exception of medications which can be safely withheld for an appropriate washout period...
- Current use of any drugs of abuse or average alcohol intake of \>21units per week over the last 3 months.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.