AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

GRoningen Early-PD Ambroxol Treatment Pharmacokinetics

This research study, called 'GRoningen Early-PD Ambroxol Treatment Pharmacokinetics,' is carefully examining a specific medicine called ambroxol. This medicine is already used for other conditions, but researchers are now interested in its potential role in Parkinson's disease. Specifically, they want to understand how the body absorbs, uses, and gets rid of ambroxol in people who are in the early stages of Parkinson's. This is an important step because understanding how the body processes a drug helps scientists work out the best doses and how often it should be taken. If ambroxol proves to work well and safely, this early research could pave the way for it to be developed as a new treatment option for Parkinson's in the future.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

16 Jul 2025

Parkinson's disease

What is this study about?

This research study is about Parkinson's disease, a condition that affects the brain and can cause problems with movement, like shaking, stiffness, and difficulty with balance. There isn't a cure for Parkinson's yet, but treatments can help manage symptoms.

Researchers are looking into an existing medicine called ambroxol. While ambroxol is currently used for other health issues, scientists believe it might also have a positive effect on Parkinson's disease. This study is focused on how your body handles ambroxol – how it's absorbed, distributed, broken down, and removed. This process is known as 'pharmacokinetics'. By understanding this, doctors can figure out the best and safest way to use the medicine.

This early stage of research is really important. If we can understand how ambroxol works in the body of someone with early Parkinson's, it helps decide if this medicine is worth studying further as a potential treatment. The goal is always to find new, effective, and safe ways to help people living with Parkinson's disease.

Key takeaways

This study is exploring an existing medicine called ambroxol for early Parkinson's disease.
The main goal is to understand how the body processes ambroxol.
This is an early stage of research to see if ambroxol has potential as a future Parkinson's treatment.
Participants must be 18 years or older and have Parkinson's disease.
Taking part involves clinic visits, health checks, and taking the study medicine.
Your participation helps advance medical science, but personal benefits are not guaranteed.

Who may be eligible?

This study is looking for people who have Parkinson's disease. To take part, you need to be aged 18 or older – there's no upper age limit.

Both men and women can join this study.

Specific details about your health and any other medicines you take will be checked by the study team to make sure it's safe and appropriate for you to participate.

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.

Do I have Parkinson's disease?
Am I 18 years old or older?
Am I able to attend study appointments regularly?
Am I comfortable taking a new medicine as part of a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be asked to attend several appointments at the study clinic. These visits would involve health checks, blood samples, and possibly other tests to see how your body is reacting to the medicine. You would be given ambroxol, the study medicine, and the team would closely monitor how your body processes it. The total duration of your involvement in the study, including all visits and follow-ups, would be explained to you in detail by the research team.

Potential risks and benefits

Taking part in a study like this could potentially help advance our understanding of Parkinson's disease and whether ambroxol could become a future treatment. However, there are no guaranteed personal benefits from participating. Like all medicines, ambroxol may have side effects, which the study team will explain fully. Your safety is a priority, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

—
Unverified
Netherlands

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain and can cause movement problems like shaking, stiffness, and balance issues.

What is ambroxol?

Ambroxol is a medicine already used for other health issues, and researchers are exploring if it could help people with Parkinson's disease.

Why are you studying how my body handles the medicine?

Understanding how your body processes a medicine helps us figure out the best and safest doses and how often it should be taken.

Will I receive treatment for Parkinson's in this study?

This early study focuses on understanding the medicine. It's not designed to be a treatment in itself, but to see if it has potential for future treatments.

Can I stop being in the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.