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A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease

Study acronym: DAPA-PD
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion moved earlier from Aug 2027 to May 2027v3 Show 4 more changesShow less
    • Study completion pushed from Feb 2028 to Jun 2028
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 15 to 18
    • Study description revised
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2025 to Feb 2, 2026
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07157735
Lead Sponsor Cambridge University Hospitals NHS Foundation Trust
Collaborators: University of Cambridge, Olatec Therapeutics, Inc., Cure Parkinson's, Van Andel Research Institute
Conditions
(from sponsor)
Parkinson Disease
Related terms Inflammation, Nerve Degeneration, Neuroinflammatory Diseases, Parkinson Disease
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov