Ambroxol to Slow Progression in Parkinson Disease
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. A diagnosis of Parkinson's disease (in accordance with the MDS diagnostic criteria) within 7 years of the screening visit confirmed by year of diagnosis. 2. Adults aged ≥ 35 and ≤ 75 years. 3. Hoehn and Yahr stage between 1-2.5, inclusive (in ON stage) at screening visit. 4. Known glucocerebrosidase gene (GBA1) status, positive or negative (status MUST be confirmed prior to screening). 5. On stable dopaminergic treatment for at least 3 months before enrolment. 6. Able and willing to provide informed consent prior to any study related assessments and/or procedures. 7. Able and willing to attend trial visits and comply with all study procedures for the duration of the trial. 8. Willing and able to self-administer oral ambroxol medication or placebo. Exclusion Criteria: 1. Participation in another interventional clinical trial of an Investigational Medicinal Product (IMP) and use of an Investigational Medicinal Product (IMP) within 90 days prior to the first dose of