ClinicaliQ Trial Snapshot
- A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson’s Disease — Recruiting • Phase II • Neurology • NCT07157735.
- What is being tested: Dapansutrile, an anti-inflammatory medication that inhibits the NLRP3 inflammasome pathway, is being evaluated to determine whether reducing neuroinflammation can slow disease progression in Parkinson's disease.
- Patient eligibility overview: The trial includes people with confirmed Parkinson's disease diagnoses; specific eligibility criteria typically encompass disease stage, age range, and absence of significant comorbidities or contraindications to the investigational drug.
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What This Trial Is Studying
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…
Eligibility Snapshot
- : 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.