Ambroxol to Slow Progression in Parkinson Disease (ASPro-PD): A phase III multi-centre randomised placebo-controlled trial
18 January 2023
Status: Trial in set-up (not recruiting)
Funder: Funding for this research has been provided by Cure Parkinson’s with Van Andel Research Institute, John Black Charitable Foundation and Parkinson’s UK.
- Trial Information
The aim of this trial is to find out whether a drug called ambroxol can slow down the progression of Parkinson’s disease. Ambroxol is an already licensed medicine in many European countries which is used to relieve mucus production in coughs and inflammation in sore throats. We hope to understand if ambroxol helps remove waste in cells, a function missing in people with Parkinson’s and whether this removal has a beneficial effect on the symptoms of the condition.
The trial will involve 330 people with Parkinson’s disease across approximately 12 clinical centres in the UK. The trial is placebo controlled, meaning half of the participants will receive ambroxol and half will receive a placebo 'dummy' drug for two years. After this, all participants will be given ambroxol for 6 months. Neither participants nor their doctors will know whether they are receiving the trial drug or the placebo 'dummy' drug. Both ambroxol and the placebo 'dummy' drug will be taken in the form of a tablet three times a day. Participants will continue to take their regular Parkinson's disease medication.
Participants will have to attend their nearest clinical centre to undergo a number of assessments before they start trial treatment and approximately every 5 months thereafter.
The trial is currently in the set-up stage, and we aim to begin recruiting people in 2024.
- Participating Hospitals
We are hoping to have clinical centres open in the following geographical areas around the UK (details of the exact NHS trusts are to be confirmed):
- West Midlands
Sites (not yet open):
- University College London Hospitals, London
- Addenbrookes NHS Trust, Cambridge
- North Cumbria Integrated Care NHS Foundation, Carlisle
- The John Radcliffe Hospital, Oxford
Contact details for the research teams at these centres will provided once available.
- Register your interest
Anyone interested in taking part in the ambroxol trial is encouraged to enrol in ‘PD Frontline’, a remote study offering online genetic testing for people with Parkinson’s. This can be done now and will help with recruiting people to the ASPro-PD trial. Further information can be found at: pdfrontline.com/en/ambroxol.
- Phase 3 clinical trial of ambroxol for Parkinson's confirmed - Cure Parkinson's (cureparkinsons.org.uk)
- Parkinson’s UK to co-fund a phase 3 stage clinical trial with Cure Parkinson’s | Parkinson's UK (parkinsons.org.uk)