Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 2: testing dapansutrile for Parkinson Disease
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: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are dapansutrile, or placebo. The registry lists allocation as randomized. 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.
They plan to enroll about 36 people at Cambridge. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
Interventions: dapansutrile, placebo
Primary outcome (registry wording): Number of adverse events (AEs) recorded during the 6-month double-blind period
Who it is for (from inclusion criteria)
Ages 50 Years to 80 Years
To be included in the trial, the potential participant must:
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
Who the registry excludes
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
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07157735?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07157735?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.