Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT07157735
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAPA-PD
Brief 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.
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.
Detailed Description:
DAPA-PD is a randomised double-blind, placebo-controlled phase II trial investigating the safety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people with early PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence of peripheral inflammation (high sensitivity C-reactive protein \[hsCRP\] \>1) as an adjunct to dopaminergic therapies. 36 participants will be recruited at a single site and treated with either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of 6 months. This randomised placebo-controlled phase of the trial will be followed by an optional 6-month open label phase, where all participants will receive the active drug. The primary endpoint will be the safety and tolerability of dapansutrile over the 6-month placebo-controlled phase.
Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 348480; 1010807 | OTHER | Integrated Research Application System | View |