AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)

This research study, called NEULARK, is looking into a new medicine called NEU-411 for people who have been diagnosed with early Parkinson's disease. The main goal is to find out if NEU-411 is safe and if it helps to improve or slow down the changes caused by Parkinson's. Some participants will receive NEU-411, while others will receive a placebo (a dummy medicine with no active ingredients). This is so researchers can compare the effects accurately. They will use a special 'Roche Parkinson's Disease application' on a digital device to measure how people are doing over a year. They will also keep a close eye on any side effects. This is a "Phase 2" study, meaning it's an important step in understanding the medicine's potential.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Neuron23 Inc.

Enrolment target

Start

19 May 2025

Parkinson Early Parkinson Disease Idiopathic Parkinson Disease Parkinson Disease Idiopathic Parkinson's disease

What is this study about?

This study is called NEULARK, and it's focused on understanding a new medicine, NEU-411, for people diagnosed with early Parkinson's disease. Parkinson's is a condition that affects the brain and can cause symptoms like tremors, stiffness, and problems with movement. This research aims to see if NEU-411 can help manage these symptoms and if it's safe for people to use.

To do this, some people in the study will receive the active medicine, NEU-411, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active ingredients. This is a common and important way to make sure that any improvements seen are definitely due to the new medicine and not just other factors, like knowing you're receiving treatment. Neither you nor your doctor will know if you're getting the medicine or the placebo during the main part of the study.

The main things researchers will be looking at are safety – how many side effects people experience – and how well the medicine works. They'll use a special digital app developed by Roche to measure changes in Parkinson's symptoms over about a year. They'll also look at how movement and other Parkinson's symptoms change using a well-known scale called the MDS-UPDRS. This study is a 'Phase 2' trial, which means it's an important step in gathering more information about this potential new treatment.

Key takeaways

This study is for people recently diagnosed with early Parkinson's disease.
It's testing a new medicine called NEU-411 to see if it's safe and effective.
Participants will receive either NEU-411 or a placebo for about one year.
A special digital app will be used to track changes in Parkinson's symptoms.
The study also carefully monitors for any side effects.
It's a 'Phase 2' study, gathering more information on this potential new treatment.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Critically, you must have been recently diagnosed with Parkinson's disease and meet specific criteria related to your diagnosis. The researchers are looking for people in the early stages of the condition. You would also need to have a positive result from a particular diagnostic test, which helps identify a specific characteristic related to Parkinson's that the new medicine is designed to target.

There will be other health requirements and medical history checks to make sure the study is safe for you and that the results will be clear. Your doctor or the study team will be able to explain all these specific details.

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?
Have you been diagnosed with Parkinson's disease relatively recently?
Are you willing to use a digital app to track your symptoms?
Are you able to attend regular clinic visits for about one year?
Are you comfortable with potentially receiving a placebo for part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to confirm you meet all the requirements. If you qualify, you will receive either the study medicine (NEU-411) or a placebo. Neither you nor your study doctor will know which one you are receiving during the first year of the study.

You would have regular visits to the study clinic, likely for check-ups, to receive your medication, and to complete assessments. These assessments will involve using a special digital app on a device to track your Parkinson's symptoms and changes. You'll also have physical exams and answer questions about how you are feeling. The main treatment part of the study lasts for about 52 weeks (just under a year). After this, there might be a short follow-up period, bringing the total time you're involved to about 54 weeks.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as access to a new medicine before it's widely available, and close medical monitoring. However, there's no guarantee the medicine will help you, or that you'll even receive the active medicine. As with any medicine, there are potential risks of side effects, which the study team will monitor very carefully. These will be fully explained to you before you decide to take part. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
Poland
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Unverified
Italy

Common questions

What is a 'placebo'?

A placebo is a dummy medicine that looks exactly like the real medicine but has no active ingredients. It's used in studies to compare against the new medicine and see if any effects are truly from the drug.

What does 'Phase 2' mean for a study?

Phase 2 means the medicine is being tested in a small group of people to see if it's safe, if it works, and to work out the right dose. It's an important step before larger studies.

Will I know if I'm getting the actual medicine or the placebo?

During the main part of the study, you (and your study doctor) will not know if you are receiving the active medicine or the placebo. This is called 'double-blind' and helps keep the results unbiased.

What is the 'Roche digital biomarker score'?

This is a score from a special app that helps researchers measure and track changes in Parkinson's symptoms over time. It's a way to objectively see how you're responding to treatment.

How long will I be involved in the study?

If you join, the main treatment part of the study will last about 52 weeks (just under a year), with a short follow-up, making your total involvement about 54 weeks.