RecruitingPHASE3INTERVENTIONAL

Ambroxol to Slow Progression in Parkinson Disease

This UK clinical trial is looking at whether a drug called ambroxol can help slow down Parkinson's disease. Ambroxol is already approved in some European countries for treating coughs and colds. The main goals of the study are to see if ambroxol can make a difference to how Parkinson's disease progresses over time and to check if it's safe and well-tolerated by people with the condition. Participants will take either ambroxol or a placebo (a dummy pill) for about two years without knowing which one they have. After that, everyone will receive ambroxol for an additional six months. This study aims to provide important information about a potential new treatment for Parkinson's.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University College, London

Enrolment target

330

Start

25 Feb 2025

Estimated completion

01 Sep 2029

Parkinson Disease

What is this study about?

This study is a clinical trial happening in the UK that's looking into a drug called ambroxol for people with Parkinson's disease. You might already know ambroxol as a medicine used to treat coughs and colds in some European countries. Researchers want to find out if this existing drug could also help slow down the progression of Parkinson's disease, which means preventing it from getting worse as quickly.

The main goals of this research are to see if ambroxol is effective in slowing the disease's progress and to make sure it's safe for people with Parkinson's. If ambroxol proves to work for Parkinson's, it could offer a new way to manage the condition. Researchers will also be carefully monitoring for any side effects.

This trial is important because finding ways to slow down Parkinson's disease could significantly improve the quality of life for many people. It's a careful and thorough process, and your involvement, if you meet the criteria and choose to participate, would be a valuable contribution to medical knowledge.

Key takeaways

Tests if ambroxol, a cold medicine, can slow Parkinson's disease.
Study lasts about 2.5 years (2 years with active drug/placebo, 6 months with only active drug).
You'll take pills three times a day.
Closer health monitoring during the trial.
Optional lumbar puncture (spinal tap) for some participants.
No guarantee of personal benefit, but helps future patients.

Who may be eligible?

To join this study, you would need to be an adult between 35 and 75 years old who has been diagnosed with Parkinson's disease within the last seven years. Your Parkinson's symptoms should be generally mild to moderate, and currently well-managed with your usual medications, which must have been stable for at least three months.

Researchers will also check your genes to understand a specific factor related to Parkinson's disease, called GBA1. You'll need to be able to take medication by mouth on your own and attend all planned study visits.

There are also some reasons why you might not be able to join. For example, if you've had certain brain surgeries, used ambroxol in the last year, or participated in other specific drug trials recently. If you have difficulty swallowing pills, or allergies to ambroxol or its ingredients, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 35 and 75 years old?
Were you diagnosed with Parkinson's disease within the last 7 years?
Are your Parkinson's medications stable for at least 3 months?
Can you swallow pills without difficulty?
Have you not used ambroxol in the past 12 months?
Are you willing and able to attend all study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a screening visit to make sure you're a good fit. If you're eligible, you'd then be randomly assigned to take either ambroxol or a dummy pill (placebo) three times a day for about two years (104 weeks). Neither you nor your study doctor will know which one you're taking during this time. The dose would slowly increase over the first two weeks.

After this main part of the study, everyone will then take ambroxol three times a day for another six months (26 weeks) in what's called an 'open-label' phase, meaning everyone knows they are receiving the active drug. Throughout the study, you'll have regular check-ups and visits with the study team to monitor your health, your Parkinson's symptoms, and any effects of the medication. The total time you would be involved in the study is about 2.5 years.

There's also an optional part of the study involving some participants where doctors might take a sample of fluid from your spine (called a lumbar puncture) a couple of times. This helps them understand how the drug is working in your body and if it reaches your brain.

Potential risks and benefits

Participating in a clinical trial has potential benefits and risks. You might benefit from closer medical monitoring and access to a potential new treatment not yet widely available. However, there's no guarantee that ambroxol will help your Parkinson's, and you might experience side effects from the medication. The placebo group wouldn't receive the active drug during the first part of the study. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (15)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham
Verified postcode
Birmingham, United Kingdom· Not yet recruiting
Southmead Hospital Bristol
Verified postcode
Bristol, United Kingdom· Not yet recruiting
Addenbrookes NHS Trust
Verified postcode
Cambridge, United Kingdom· Not yet recruiting
Western General Hospital
Verified postcode
Edinburgh, United Kingdom· Not yet recruiting
Kings College London
Verified postcode
London, United Kingdom· Not yet recruiting
Royal London Hospital
Verified postcode
London, United Kingdom· Not yet recruiting
University College London Hospital's
Verified postcode
London, United Kingdom· Recruiting
Newcastle
Verified postcode
Newcastle, United Kingdom· Not yet recruiting
Northumbria
Verified postcode
Newcastle upon Tyne, United Kingdom· Not yet recruiting
The John Radcliffe Hospital
Verified postcode
Oxford, United Kingdom· Not yet recruiting
Derriford Hospital
Verified postcode
Plymouth, United Kingdom· Recruiting
Fairfield General Hospital
Verified postcode
Salford, United Kingdom· Not yet recruiting

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain and can cause problems with movement, such as tremors, stiffness, and slow movement.

What is ambroxol?

Ambroxol is a medicine that's already used in some countries to help with coughs and colds. This study is exploring if it can also help with Parkinson's disease.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the active drug.

Will I know if I'm taking the real drug or the placebo?

For the first two years of the study, neither you nor your doctors will know if you're taking ambroxol or the placebo. For the last six months, everyone will receive ambroxol.

What is a lumbar puncture?

A lumbar puncture is a medical procedure where a small needle is used to collect a sample of fluid from your lower back, from around your spinal cord. This is optional in this study.

How to find out more

ASPro-PD Trial Team

cctu.aspro-pd@ucl.ac.uk 02031084908 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.