Active not recruitingPHASE3INTERVENTIONAL

Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations

This study aims to find out if a new way of giving Parkinson's medication, called ND0612, is effective, safe, and well-tolerated. ND0612 is given continuously through a small pump placed under the skin. Researchers want to see how it compares to the standard Parkinson's tablets (immediate-release levodopa/carbidopa) for people whose symptoms, like movement difficulties, fluctuate throughout the day. It's a large study involving many centres, where some participants will receive the new treatment, others the standard tablets, and some placebos, all in a carefully planned way to ensure fair results. The goal is to see if this new method can help manage Parkinson's symptoms more consistently.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

NeuroDerm Ltd.

Enrolment target

381

Start

30 Sep 2019

Estimated completion

01 Feb 2027

Parkinson's Disease

What is this study about?

This research study is investigating a new treatment approach for Parkinson's disease, specifically for people who experience what are called 'motor fluctuations.' This means your Parkinson's symptoms, such as tremors, stiffness, or slow movement, can change quite a bit throughout the day, sometimes being well-controlled ('on' time) and other times becoming more severe ('off' time).

The study treatment, called ND0612, is designed to deliver a key Parkinson's medication (levodopa/carbidopa) continuously under the skin using a small pump. The idea is that a steady supply of medication might help to reduce these daily 'on-off' fluctuations compared to taking tablets multiple times a day. We want to understand if ND0612 helps people feel better, is safe to use, and is comfortable for them.

This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use. It's designed very carefully to make sure the results are reliable. It compares ND0612 against the standard tablets you might already be taking, and also uses 'placebos' – treatments that look like the real thing but contain no active medicine. This helps researchers understand the true effects of the new treatment.

Key takeaways

This study is testing a new way to give Parkinson's medication (ND0612) via a small pump under the skin.
It aims to reduce daily 'on-off' fluctuations in Parkinson's symptoms.
The new treatment is compared to standard Parkinson's tablets and a placebo.
It's for people with Parkinson's aged 30+ who experience significant 'off' times.
Participation involves several stages, including medication adjustments and regular check-ups.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for both men and women aged 30 or older who have Parkinson's disease. Your Parkinson's diagnosis needs to match specific criteria, and your symptoms shouldn't be too severe when your medication is working well.

Crucially, you would need to be experiencing at least two and a half hours of 'off' time (when your medication isn't working as well) each day. You should also be taking levodopa/carbidopa tablets at least four times a day, with a total daily dose of at least 400mg.

You wouldn't be able to join if you have other types of Parkinson's-like conditions, have had brain surgery for Parkinson's, or are currently using certain other Parkinson's treatments like duodenal infusions or apomorphine infusions. Also, if you've previously taken part in studies for ND0612 or have significant skin problems, you wouldn't be eligible.

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 30 years old or older with Parkinson's disease?
Do you experience at least 2.5 hours of 'off' time every day?
Are you currently taking levodopa/carbidopa tablets at least 4 times a day?
Have you *not* had brain surgery for Parkinson's or used certain other advanced Parkinson's therapies?
Do you have a diagnosis of typical Parkinson's disease, not another similar condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages over a period of time. Initially, there's a screening check to make sure you're suitable. Then, you'll have a period where your current oral Parkinson's medication (levodopa/carbidopa tablets) might be adjusted to the best dose for you. Following this, you'll switch to the ND0612 treatment, and the dosage will be carefully adjusted to find what works best.

After these adjustment phases, you'll enter the main part of the study. During this time, you'll be randomly assigned to receive either the ND0612 treatment or a matching placebo, along with your usual oral medication. Neither you nor your doctor will know which treatment you are receiving (this is called 'double-blind'). There will also be regular visits to the clinic for check-ups, assessments of your Parkinson's symptoms, and safety monitoring.

Once this main period is over, you might have the option to continue with the ND0612 treatment in an open-label extension period, where everyone receives the active drug and knows they are receiving it. Finally, there will be a safety follow-up after your treatment ends. The total duration of your participation will depend on these stages and whether you join the extension.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which could lead to improved symptom control or quality of life if the ND0612 treatment is effective for you. However, there are also potential risks involved, such as side effects from the medication, discomfort from the injection site, or the possibility that the treatment may not work for you. As with any medical study, there's a chance you might receive a placebo without active medication during parts of the trial. All potential risks will be thoroughly explained to you, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (103)

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

Xenoscience
Verified postcode
Phoenix, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Cedar- Sinai Medical Center Department of Neurology
Verified postcode
Los Angeles, United States
SC3 Research - Reseda
Verified postcode
Reseda, United States
University of California San Francisco
Verified postcode
San Francisco, United States
Rocky Mountain Movement Disorders Center
Verified postcode
Englewood, United States
Hartford Healthcare Chase Family Movement Disorders Center
Verified postcode
Vernon, United States
Visionary Investigators Network
Verified postcode
Aventura, United States
Parkinsons Disease and Movement Disorders Center of Boca Raton
Verified postcode
Boca Raton, United States
University of Florida Norman Fixel Institute for Neurological Diseases
Verified postcode
Gainesville, United States
Neurology Associates PA
Verified postcode
Maitland, United States
USF Parkinson's Disease and Movement Disorders Center
Verified postcode
Tampa, United States

Common questions

What are 'motor fluctuations'?

These are when your Parkinson's symptoms, like tremor or stiffness, switch between being well-controlled ('on') and becoming more noticeable and difficult ('off') throughout the day.

What does 'ND0612 solution for SC infusion' mean?

It means the study drug, ND0612, is a liquid that is given continuously under the skin ('subcutaneous' or SC) using a small pump.

What is a 'placebo'?

A placebo looks exactly like the actual treatment but doesn't contain any active medicine. It helps researchers understand the real effects of the drug.

Why is it 'double-blind'?

This means neither you nor your doctors will know whether you are receiving the active ND0612 treatment or the placebo. This helps make the study results as fair and unbiased as possible.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time, for any reason. Your decision will not affect your routine medical care.