At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ambroxol Hydrochloride (420mg) (drug), Placebo (drug)
- How long the study runs
- Study runs about 55 months (dates as stated)
- About the drug or intervention
- Ambroxol Hydrochloride (420mg) — drug: Oral tablet · Placebo — drug: Oral tablet
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 35 Years to 75 Years
- Who
- All
- Number of participants
- 330
- Started
- 2025-02-25
- Last checked
- 2025-04
Plain English Summary
What is this study?
- • Testing a new treatment for parkinson disease
- • Phase3 - 330 participants
- • 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
Who can take part?
- • Ages 35 Years to 75 Years
- • Diagnosed with parkinson disease
Where?
- • Birmingham - University Hospitals Birmingham
- • Bristol - Southmead Hospital Bristol
- • Cambridge - Addenbrookes NHS Trust
- • Edinburgh - Western General Hospital
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a 104-week, randomized, double-blind, multi-centre, parallel group, placebo-controlled clinical trial of ambroxol hydrochloride in patients with PD, with a 26-week open-label extension phase. Participants will undergo screening to evaluate their eligibility to participate in the trial. All eligible participants will be randomised to receive either ambroxol hydrochloride (420mg) or it's matching placebo in a 1:1 ratio three times a day for 104 weeks, including a 2-week dose escalation period. Once the end of the blinded treatment has been reached, all participants will enter the open-label extension phase and will receive ambroxol hydrochloride (420mg) three times a day for 26 weeks, including a 2-week dose escalation period. All clinical staff, study investigators, and participants will be blinded to study assignments throughout the entirety of the trial. There will be an optional sub-study including 106 participants in which a cerebrospinal fluid (CSF) sample will be taken on two occasions via a Lumbar Puncture procedure to measure ambroxol drug levels, assess whether the glucocerebrosidase enzyme has been stimulated and the levels of other substances thought to be associated with the development of PD and confirm whether the study drug has penetrated the cerebrospinal fluid and Central Nervous System.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 35 Years - 75 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓A diagnosis of Parkinson's disease (in accordance with the MDS diagnostic criteria) within 7 years of the screening...
- ✓Adults aged ≥ 35 and ≤ 75 years.
- ✓Hoehn and Yahr stage between 1-2.5, inclusive (in ON stage) at screening visit.
- ✓Known glucocerebrosidase gene (GBA1) status, positive or negative (status MUST be confirmed prior to screening).
- ✓On stable dopaminergic treatment for at least 3 months before enrolment.
Who cannot take part
- ✗Use of an Investigational Medicinal Product (IMP) within 90 days prior to the first dose of trial treatment.
- ✗Participation in another clinical trial of an Investigational New Drug being tested for PD disease modifying...
- ✗Past surgical history of deep brain stimulation.
- ✗Use of ambroxol in the past 12 months.
- ✗Exposure to Exenatide within 12 months prior to the first dose in this current trial.
See the full criteria
Where Is This Study? (15 UK sites)
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
How to Get in Touch
ASPro-PD Trial Team
Sponsor contactCONTACT
Felicia Ikeji
Sponsor contactCONTACT
