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Looking for participantsPhase3

Ambroxol to Slow Progression in Parkinson Disease

Sponsor: University College, London

NCT ID: NCT05778617

View on ClinicalTrials.gov ↗

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.

Parkinson Disease

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What we know so far

Condition· Matched your search
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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

positive or negative

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
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.

Where Is This Study? (15 UK sites)

University Hospitals Birmingham

Birmingham, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ben Wright, DrPrincipal Investigator

Southmead Hospital Bristol

Bristol, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Alan Whone, DrPrincipal Investigator

Addenbrookes NHS Trust

Cambridge, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Caroline Williams-Gray, DrPrincipal Investigator

Western General Hospital

Edinburgh, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
David Breen, DrPrincipal Investigator

Kings College London

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Ray Chaudhuri, Prof.Principal Investigator

Royal London Hospital

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Alastair Noyce, Prof.Principal Investigator

University College London Hospital's

London, United Kingdom

Recruiting
Site contact (verified)
Marco Toffoli, DrPrincipal Investigator

Newcastle

Newcastle, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Nicola Pavese, Prof.Principal Investigator

Northumbria

Newcastle upon Tyne, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
James Fisher, DrPrincipal Investigator

The John Radcliffe Hospital

Oxford, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Michele Hu, Prof.Principal Investigator

Derriford Hospital

Plymouth, United Kingdom

Recruiting
Site contact (verified)
Stephen Mullin, DrPrincipal Investigator

Fairfield General Hospital

Salford, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Robert Irving, DrPrincipal Investigator

Salford Royal Hospital

Salford, United Kingdom

Recruiting
Site contact (verified)
Monty Silverdale, Prof.Principal Investigator

Southampton General Hospital

Southampton, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Boyd Ghosh, DrPrincipal Investigator

Prince Philip Hospital

Wales, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Mark Sheehan, DrPrincipal Investigator

How to Get in Touch

ASPro-PD Trial Team

Sponsor contact

CONTACT

02031084908 cctu.aspro-pd@ucl.ac.uk

Felicia Ikeji

Sponsor contact

CONTACT

02076799506 f.ikeji@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-04