RecruitingPhase 3NCT05778617

Ambroxol to Slow Progression in Parkinson Disease

Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial


Sponsor

University College, London

Enrollment

330 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a UK only clinical trial in patients with Parkinson's disease (PD) of a drug called ambroxol hydrochloride, which is an already licensed drug for the treatment of respiratory conditions (such as a common cold) in many European countries. The aim of this trial is to find out whether ambroxol hydrochloride can slow down the progression of Parkinson's disease and to evaluate it's safety and tolerability.


Eligibility

Min Age: 35 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ambroxol — a drug commonly used for coughs — can slow the progression of Parkinson's disease. Ambroxol activates an enzyme that may clear out a protein thought to drive Parkinson's, and researchers want to see whether it can meaningfully affect disease progression, especially in people with a genetic variant (GBA1 gene) associated with increased Parkinson's risk. **You may be eligible if:** - You have been diagnosed with Parkinson's disease within the last 7 years - You are between 35 and 75 years old - Your Parkinson's symptoms are mild to moderate (Hoehn and Yahr stage 1–2.5) - You have confirmed GBA1 gene status (positive or negative — both are eligible) - You have been on a stable Parkinson's medication regimen for at least 3 months **You may NOT be eligible if:** - Your Parkinson's was diagnosed more than 7 years ago - You have more advanced disease (Hoehn and Yahr stage above 2.5) - You are under 35 or over 75 years old - Your GBA1 status has not been confirmed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAmbroxol Hydrochloride (420mg)

Oral tablet

DRUGPlacebo

Oral tablet


Locations(15)

University Hospitals Birmingham

Birmingham, United Kingdom

Southmead Hospital Bristol

Bristol, United Kingdom

Addenbrookes NHS Trust

Cambridge, United Kingdom

Western General Hospital

Edinburgh, United Kingdom

Kings College London

London, United Kingdom

Royal London Hospital

London, United Kingdom

University College London Hospital's

London, United Kingdom

Newcastle

Newcastle, United Kingdom

Northumbria

Newcastle upon Tyne, United Kingdom

The John Radcliffe Hospital

Oxford, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

Fairfield General Hospital

Salford, United Kingdom

Salford Royal Hospital

Salford, United Kingdom

Southampton General Hospital

Southampton, United Kingdom

Prince Philip Hospital

Wales, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05778617


Related Trials