Actively Recruiting
Ambroxol to Slow Progression in Parkinson Disease
Led by University College, London · Updated on 2025-05-01
330
Participants Needed
15
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ambroxol to Slow Progression in Parkinson Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Parkinson's disease within 7 years confirmed by year of diagnosis
- Adults aged 35 to 75 years
- Hoehn and Yahr stage between 1 and 2.5 (inclusive) during ON stage at screening
- Known glucocerebrosidase gene (GBA1) status confirmed before screening
- On stable dopaminergic treatment for at least 3 months before enrolment
- Able and willing to give informed consent before any study procedures
- Able and willing to attend all trial visits and follow study procedures
- Willing and able to self-administer oral ambroxol or placebo medication
You will not qualify if you...
- Participation in another investigational medicinal product trial or use within 90 days prior to first trial dose
- Participation in a Parkinson's disease investigational drug trial within 12 months prior to first trial dose
- Past surgery involving deep brain stimulation
- Use of ambroxol in the past 12 months
- Exposure to Exenatide within 12 months prior to first dose in this trial
- Use of medications like exenatide or other GLP1 agonists for diabetes that preclude study participation
- Confirmed swallowing difficulties preventing self-administration of ambroxol
- Known allergies to ambroxol or its ingredients
- Known rare hereditary disorders related to galactose intolerance or similar
- Presence of LRRK2 G2019S mutation confirmed before screening
- History of drug abuse or alcoholism affecting trial participation
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Women of childbearing potential and male partners not willing to use effective contraception during and 2 weeks after treatment
- Any significant or unstable medical or surgical condition posing risk or affecting participation or study results
- Severe depression (Beck Depression Inventory-II score >20) at screening
- Significant cognitive impairment (Montreal Cognitive Assessment score <20) at screening
- Use of trihexyphenidyl or benztropine within 30 days before first trial dose
- For CSF sub-study participants: hypersensitivity to lidocaine or derivatives
- For CSF sub-study participants: current anticoagulant use that may preclude safe lumbar puncture, except aspirin
- For CSF sub-study participants: spinal abnormalities preventing lumbar puncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University Hospitals Birmingham
Birmingham, United Kingdom
Not Yet Recruiting
2
Southmead Hospital Bristol
Bristol, United Kingdom
Not Yet Recruiting
3
Addenbrookes NHS Trust
Cambridge, United Kingdom
Not Yet Recruiting
4
Western General Hospital
Edinburgh, United Kingdom
Not Yet Recruiting
5
Kings College London
London, United Kingdom
Not Yet Recruiting
6
Royal London Hospital
London, United Kingdom
Not Yet Recruiting
7
University College London Hospital's
London, United Kingdom
Actively Recruiting
8
Newcastle
Newcastle, United Kingdom
Not Yet Recruiting
9
Northumbria
Newcastle upon Tyne, United Kingdom
Not Yet Recruiting
10
The John Radcliffe Hospital
Oxford, United Kingdom
Not Yet Recruiting
11
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
12
Fairfield General Hospital
Salford, United Kingdom
Not Yet Recruiting
13
Salford Royal Hospital
Salford, United Kingdom
Actively Recruiting
14
Southampton General Hospital
Southampton, United Kingdom
Not Yet Recruiting
15
Prince Philip Hospital
Wales, United Kingdom
Not Yet Recruiting
Research Team
A
ASPro-PD Trial Team
CONTACT
F
Felicia Ikeji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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