Active not recruitingOBSERVATIONAL

Long-Term Observational Study on Effectiveness and Safety of Lecigon in Patients With Advanced Parkinson's Disease

This study is gathering real-world information about a medicine called Lecigon®, which is used for advanced Parkinson's disease. Lecigon® is prescribed when people experience uncontrollable changes in their movement that swallowing medicines can't properly control. This study isn't testing a new treatment; it's observing how Lecigon® works for people already using it in their daily care. It will collect details on how well it helps symptoms and if there are any side effects. This helps researchers understand the medicine better outside of strict clinical trials. Around 300 patients will take part, providing valuable insights into living with Lecigon® and advanced Parkinson's.

At a glance

Status

Active not recruiting

Sponsor

Britannia Pharmaceuticals Ltd.

Enrolment target

312

Start

06 Jul 2021

Estimated completion

01 Sep 2026

Advanced Parkinson Disease

What is this study about?

This study is all about understanding how a medicine called Lecigon® works in real life for people with advanced Parkinson's disease. You might be wondering what 'advanced Parkinson's disease' means. It refers to a stage where people often experience difficult-to-control changes in their movement, sometimes called 'motor fluctuations', which can't be properly managed with their usual swallowed medicines.

Lecigon® is a treatment that doctors might prescribe in these situations. This study isn't testing if Lecigon® works – that's already been done in earlier research. Instead, it's designed to see how the medicine performs for people in their day-to-day lives, outside of a strict research setting. It will gather information on how effective Lecigon® is at helping symptoms and whether there are any side effects.

Researchers will collect this information from about 300 patients who are already using Lecigon®. This helps them get a complete picture of the treatment's strengths and weaknesses when used by many different people in various situations. The study hopes to add to our understanding of Lecigon® and ultimately help improve care for people with advanced Parkinson's disease.

Key takeaways

This study observes real-world use of Lecigon® for advanced Parkinson's.
It's for people already prescribed Lecigon®, not for testing a new drug.
Data collected will include how well Lecigon® works and any side effects.
Participation will not involve extra doctor visits or changes to your care.
The findings will help improve understanding and care for others.
You can stop participating at any time without affecting your treatment.

Who may be eligible?

To be part of this study, you must be at least 18 years old and already have advanced Parkinson's disease. Importantly, you need to be currently taking Lecigon® treatment, and you must have started it no more than three months before agreeing to join the study. Your Lecigon® treatment should also be in line with how doctors are generally advised to prescribe it.

You or a legal representative will need to sign a consent form to show you understand and agree to take part. Also, you cannot be involved in another clinical research study at the same time.

There are some reasons why you might not be able to join. For example, if your doctor has advised against using Lecigon® for you, or if you won't be able to attend follow-up appointments at your doctor's office. Also, if there are significant issues with using the pump that delivers the medicine, such as serious illness, inability to manage the pump, or severe memory problems, agitation, or alcohol or drug misuse, you might not be suitable.

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 18 years old or older?
Do you have advanced Parkinson's disease?
Are you already taking Lecigon® (started within the last 3 months)?
Are you able to provide consent (or does a legal representative)?
Are you not currently in another clinical research study?
Do you *not* have any health conditions that your doctor has advised against using Lecigon® for?

Answer every question to see your result.

What does participation involve?

If you join this study, it's important to know that it generally won't change your usual medical care. Your doctor has already decided that Lecigon® is the right treatment for you. This study doesn't involve any extra mandatory doctor visits or tests just for the research. Instead, the study will gather information during your regular appointments.

Researchers will collect details about how Lecigon® is working for you and if you've experienced any side effects during your routine visits. For those who started Lecigon® a little while before joining the study, some information from your past medical records might be used. The total duration of your participation will depend on how long you continue to use Lecigon® as part of your ongoing care.

Potential risks and benefits

The main benefit of taking part is contributing to a better understanding of Lecigon® for future patients. There are no direct medical benefits to you from participating, as you're already receiving Lecigon® as part of your normal care. As this study only collects information from your existing treatment, there are generally no additional risks beyond those already associated with Lecigon® treatment itself, which your doctor would have discussed with you. Remember, you can choose to withdraw from the study at any time without affecting your medical care.

Locations (57)

Universitätsklinik für Neurologie, Medizinische Universität Graz
Verified postcode
Graz, Austria
Abteilung für Neurologische Rehabilitation, Gailtal-Klinik
Verified postcode
Hermagor, Austria
Universitätsklinik für Neurologie, Medizinische Universität Innsbruck
Verified postcode
Innsbruck, Austria
Kepler Universitätsklinikum
Verified postcode
Linz, Austria
AZ Sint-Jan
Verified postcode
Bruges, Belgium
Antwerp University Hospital
Verified postcode
Edegem, Belgium
Ghent University Hospital
Verified postcode
Ghent, Belgium
University Hospital Liege
Verified postcode
Liège, Belgium
Centre Hospitalier de Wallonie picarde (Chwapi)
Verified postcode
Tournai, Belgium
Sveti Naum
Verified postcode
Sofia, Bulgaria
UHC Osijek, J. Klinici za neurologiju
Verified postcode
Osijek, Croatia
University Hospital Centre Rijeka (KBC Rijeka)
Verified postcode
Rijeka, Croatia

Common questions

What is the main goal of this study?

The main goal is to understand how Lecigon® works and its safety for people with advanced Parkinson's disease in their everyday lives.

Will I receive a new medicine?

No, you will not receive a new medicine. This study is for people who are already being treated with Lecigon® by their doctor.

Do I need extra doctor appointments for the study?

No, the study will collect information during your regular appointments. There are no extra mandatory visits just for the study.

What kind of information will be collected?

Information about how well Lecigon® is working for your symptoms, your quality of life, and any side effects you might experience will be collected.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and it will not affect your medical care.