Ambroxol for Slowing Progression in Parkinson's Disease

Ambroxol to Slow Progression in Parkinson Disease

Recruiting Phase 3 Interventional Study
Parkinson Disease
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
35 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
330 (estimated)
Sponsor
University College, London · Other
Who this trial is looking for

This trial is looking for adults with Parkinson's disease to see if a drug called ambroxol can slow its progression. Participants will receive either ambroxol or a placebo and will need to attend regular visits during the trial.

Are You a Good Fit for This Trial?
Must be taking Dopaminergic treatment
Rules you out LRRK2 G2019S mutationDrug abuse historyAlcoholism

You may be able to join if

  • I have been diagnosed with Parkinson's disease in the last 7 years.
  • I am between 35 and 75 years old.
  • I have a Hoehn and Yahr stage of 1 to 2.5.
  • I know my glucocerebrosidase gene status.
  • I have been on stable dopaminergic treatment for at least 3 months.
  • I can provide informed consent.
  • I can attend trial visits and follow study procedures.
  • I can self-administer oral ambroxol or placebo.

You may not be able to join if

  • I have participated in another clinical trial in the past 90 days.
  • I have used ambroxol in the past 12 months.
  • I have had deep brain stimulation surgery.
  • I have confirmed dysphagia that prevents me from taking medication.
  • I have a known sensitivity to ambroxol or its ingredients.
  • I am pregnant or breastfeeding.
  • I have severe depression or significant cognitive impairment.
  • I have an unstable medical condition that could affect my participation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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 t…
Trial Locations
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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. …
Contacts

ASPro-PD Trial Team

02031084908

cctu.aspro-pd@ucl.ac.uk

CONTACT

Felicia Ikeji

02076799506

f.ikeji@ucl.ac.uk

CONTACT