Recruiting · registry statusCan ambroxol slow changes in Parkinson’s?
Researchers in the UK test whether ambroxol, a medicine used for some breathing conditions, can slow the progression of Parkinson’s.
Testing a treatment or activity · Study reference: NCT05778617
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported actual date)
- 2025-02-25
- Main measurements finished (planned)
- 2029-02
- Study finished (planned)
- 2029-09
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 35 years to 75 years · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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 trial treatment.
2. Use of an Investigational Medicinal Product (IMP) within 90 days prior to the first dose of trial treatment.
3. Participation in another clinical trial of an Investigational New Drug being tested for PD disease modifying potential within 12 months prior to the first dose of trial treatment.
4. Past surgical history of deep brain stimulation.
5. Use of ambroxol in the past 12 months.
6. Exposure to Exenatide within 12 months prior to the first dose in this current trial.
7. Concomitant medications that in the opinion of the Investigator would preclude participation in the study e.g., exenatide or other GLP1 agonist for diabetes.
8. Confirmed dysphagia that would preclude self-administration of ambroxol.
9. History of known sensitivity to the study medication, ambroxol or its excipients (lactose monohydrate, granulated microcrystalline cellulose, copovidone and magnesium stearate) in the opinion of the investigator that contraindicates their participation.
10. History of known rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
11. Presence of the LRRK2 G2019S mutation (status to be confirmed prior to screening).
12. History of drug abuse or alcoholism in the opinion of the Investigator that would preclude participation in the trial.
13. Pregnant (or planned pregnancy during the trial) and/or breastfeeding.
14. Women of childbearing potential (WOCBP) and male participants with a partner of childbearing potential not willing to use highly effective contraception or abstinence for the duration of the trial treatment and for 2 weeks following the last dose of the study drug.
15. Any clinically significant or unstable medical or surgical condition that in the opinion of the Investigator may; put the participant at risk when participating in the study, influence the results of the study or affect the participants ability to take part in the study, as determined by medical history, physical examinations, electrocardiogram (ECG) or laboratory tests. Such conditions may include:
A. Impaired renal function with creatinine clearance \<50ml/min at screening visit.
B. Moderate/Severe hepatic impairment.
C. A major cardiovascular event (e.g., myocardial infarction, acute coronary syndrome, compensated congestive heart failure, pulmonary embolism, coronary revascularisation) that occurred within 6 months prior to the screening visit.
16. Severe depression defined by a score \>20 on the Beck Depression Inventory-II (BDI-II) at screening.
17. Significant cognitive impairment defined by a score \<20 on the Montreal Cognitive Assessment (MoCA) at screening.
18. Use of trihexyphenidyl or benztropine within 30 days prior to the first dose of trial treatment.
19. Only applicable for those patients consenting to the optional CSF sub-study: Evidence or history of hypersensitivity to lidocaine or its derivatives.
20. Only applicable for those patients consenting to the optional CSF sub-study: current treatment with anti-coagulants (e.g., warfarin) that might preclude safe completion of the lumbar puncture in the opinion of the Investigator. Aspirin will be permitted.
21. Only applicable for those patients consenting to the optional CSF sub-study: Significant known lower spinal malformations or other spinal abnormalities that would preclude a lumbar puncture.
Full study name & original research details
Official study title
Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial
Short title used by the registry
Ambroxol to Slow Progression in Parkinson Disease
Original description
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.
Further description from the registry
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.
Conditions reported: Parkinson Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- Ambroxol Hydrochloride (420mg); Placebo
- Phases
- PHASE3
- Sponsor
- University College, London
- Start date reported by registry
- 2025-02-25 (actual)
Registry updated: 2025-05-01 · Status last verified by the registry submitter: 2025-04
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
ASPro-PD Trial Team · 02031084908 · cctu.aspro-pd@ucl.ac.uk
Felicia Ikeji · 02076799506 · f.ikeji@ucl.ac.uk
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
University Hospitals Birmingham
Birmingham, United Kingdom
Not yet recruitingBen Wright
Ben Wright, Dr
Southmead Hospital Bristol
Bristol, United Kingdom
Not yet recruitingAlan Whone
Alan Whone, Dr
Addenbrookes NHS Trust
Cambridge, United Kingdom
Not yet recruitingCaroline Williams-Gray
Caroline Williams-Gray, Dr
Western General Hospital
Edinburgh, United Kingdom
Not yet recruitingDavid Breen
David Breen, Dr
Kings College London
London, United Kingdom
Not yet recruitingRay Chaudhuri
Ray Chaudhuri, Prof.
Royal London Hospital
London, United Kingdom
Not yet recruitingAlastair Noyce
Alastair Noyce, Prof.
University College London Hospital's
London, United Kingdom
RecruitingMarco Toffoli
Marco Toffoli, Dr
Newcastle
Newcastle, United Kingdom
Not yet recruitingNicola Pavese
Nicola Pavese, Prof.
Northumbria
Newcastle upon Tyne, United Kingdom
Not yet recruitingJames Fisher
James Fisher, Dr
The John Radcliffe Hospital
Oxford, United Kingdom
Not yet recruitingMichele Hu
Michele Hu, Prof.
Derriford Hospital
Plymouth, United Kingdom
RecruitingStephen Mullin
Stephen Mullin, Dr
Fairfield General Hospital
Salford, United Kingdom
Not yet recruitingRobert Irving
Robert Irving, Dr
Salford Royal Hospital
Salford, United Kingdom
RecruitingMonty Silverdale
Monty Silverdale, Prof.
Southampton General Hospital
Southampton, United Kingdom
Not yet recruitingBoyd Ghosh
Boyd Ghosh, Dr
Prince Philip Hospital
Wales, United Kingdom
Not yet recruitingMark Sheehan
Mark Sheehan, Dr
Facility not reported
United Kingdom
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.