DAPA-PD
Research type
Research Study
Full title
Anti-inflammatory Intervention with Dapansutrile (OLT1177®) for Parkinson’s Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
IRAS ID
1010807
Contact name
Caroline Williams-Gray
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
ISRCTN Number
ISRCTN16806940
Research summary
In Parkinson’s disease, an area of the brain called the substantia nigra, loses nerve cells (called neurons) which produce a chemical called dopamine. Dopamine plays a vital role in regulating the movement of the body, and a reduction of dopamine is responsible for many of the symptoms of Parkinson’s disease. Research has suggested that inflammation in the brain may contribute to this loss of nerve cells.
We want to find out whether using a medication called dapansutrile can reduce inflammation in the brain in people with Parkinson’s, and whether it has an impact on the progression of Parkinson’s disease.
Dapansutrile is a medication which acts by suppressing inflammation. Dapansutrile is not yet licensed, which means it is not approved for use in any disease area or in any country. However, it has been used in clinical trials, including in people with heart failure, acute gout, COVID-19, and melanoma. In these trials, dapansutrile has been shown to be safe for use in people.
There are two main parts of the trial:
- Randomised, placebo-controlled phase: where two thirds of the participants will receive dapansutrile or one third will receive a ‘dummy drug’ called a placebo for 26 weeks. Neither the participant nor the trial doctor will know which treatment is being taken, although the trial doctor can find out if necessary.
- Optional open-label phase: where all participants who agree to take part in this section will receive dapansutrile for an additional 26 weeks (whether or not they have received dapansutrile in the first part).The trial is being conducted in Cambridge. Participants will need to attend 10 in-person visits during the randomised, placebo-controlled phase. If the participant does not wish to continue to the optional open-label phase, they will attend one final in-person visit. If they do agree to take part in the open-label phase, they will attend an additional 7 visits during the open-label phase.
REC name
London - City & East Research Ethics Committee
REC reference
25/LO/0097
Date of REC Opinion
7 Mar 2025
REC opinion
Further Information Favourable Opinion