AuthorisedTherapeutic confirmatory (Phase III)Interventional

EFFECTS OF SAFINAMIDE VERSUS PLACEBO ON PAIN IN PATIENTS WITH PARKINSON’S DISEASE WITH MOTOR FLUCTUATIONS: A RANDOMIZED, CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL. Protocol code: SAVE PAIN 2025

This research study, called SAVE PAIN 2025, is investigating whether a medication named safinamide can help manage pain experienced by individuals with Parkinson's disease. Specifically, it's for those who have 'motor fluctuations,' meaning their movement symptoms can vary unpredictably through the day. The study is a Phase III trial, which means it's a key step to see if the drug is effective and safe before it could be approved for wider use. Participants will either receive safinamide or a placebo (a tablet that looks the same but contains no active medicine). The main aim is to see if safinamide can reduce pain levels more than the placebo over 12 weeks. Researchers will also look at how it affects other Parkinson's symptoms and quality of life.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrolment target

Start

05 Aug 2025

PARKINSON’S DISEASE WITH MOTOR FLUCTUATIONS

What is this study about?

This study, known as SAVE PAIN 2025, is a research project designed to help us understand if a specific medicine, called safinamide, can ease pain for people living with Parkinson's disease. It's particularly focused on those who experience 'motor fluctuations.' This term simply means that their Parkinson's symptoms, like tremor or stiffness, can change quite a bit throughout the day, sometimes being well controlled and other times being more difficult. Pain can be a real problem for people with Parkinson's, and finding effective ways to manage it is very important.

In this study, researchers will compare safinamide against a 'placebo.' A placebo is a tablet that looks identical to the active medicine but doesn't contain any drug. This is done to make sure that any improvements seen are genuinely due to the safinamide and not just because someone expects to feel better. Neither the participants nor their doctors will know whether they are receiving safinamide or the placebo—this helps keep the study results fair and unbiased.

The main goal of the study is to see if, after 12 weeks, people taking safinamide experience a bigger reduction in their pain levels compared to those taking the placebo. Researchers will also be looking at other important aspects, such as how the medication might affect movement symptoms and overall quality of life for people with Parkinson's. This type of study, called a Phase III trial, is crucial for determining if a new treatment is safe and effective enough to potentially become a widely available option.

Key takeaways

The study investigates whether safinamide can reduce pain in Parkinson's patients with motor fluctuations.
It's a 'blinded' study, meaning you won't know if you're taking the active drug or a placebo.
The main goal is to see if safinamide reduces pain more than the placebo over 12 weeks.
Researchers will also look at how it affects other Parkinson's symptoms and quality of life.
Participation involves regular clinic visits and medication for 12 weeks.
You have the right to leave the study at any point.

Who may be eligible?

This study is looking for both men and women aged 18 and over. There is no upper age limit, so people of all adult ages can be considered.

To be eligible, you must have Parkinson's disease and experience 'motor fluctuations.' This means your movement symptoms, like tremors or stiffness, tend to vary or change noticeably throughout your day, even with your usual Parkinson's medications.

It's important to remember that these are just the basic requirements. There will be other health checks and medical criteria that a study doctor will need to go through with you to determine if you can safely take part. For instance, they'll review your full medical history and current medications.

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 a diagnosis of Parkinson's disease?
Do you experience 'motor fluctuations' (your Parkinson's symptoms change during the day)?
Are you able to attend regular clinic appointments for 12 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in the study for a total of 12 weeks. During this time, you will have regular visits to the study clinic where the research team can monitor your health and how you are responding to the treatment. You will receive either the study drug (safinamide) or a placebo (a dummy pill) for the duration of the 12 weeks. Both the study drug and placebo are film-coated tablets that you will take as instructed by the study team. At each visit, various assessments will be carried out; these might include questionnaires about your pain and quality of life, and physical examinations to assess your Parkinson's symptoms. This structured approach helps the researchers gather accurate information about the treatment's effects. After the 12 weeks of treatment, there will be a final check-up to wrap up your participation.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and potential risks. You might benefit if safinamide helps to reduce your pain or improves other Parkinson's symptoms more than your current treatment. However, there's also a chance you could receive the placebo and not experience any direct benefit from the study drug. Safinamide, like all medications, can have side effects, and your healthcare team will discuss these with you thoroughly. You will be closely monitored for any reactions or changes in your health throughout the study. Remember, your participation is completely voluntary, and you have the right 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.

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Unverified
Italy

Common questions

What are 'motor fluctuations' in Parkinson's disease?

Motor fluctuations mean your Parkinson's movement symptoms (like tremor, stiffness, or slow movement) change unpredictably throughout the day, sometimes being well managed and other times being more noticeable, even with your usual medication.

What is a 'placebo' in a study?

A placebo is a tablet that looks exactly like the study drug but doesn't contain any active medicine. It's used to compare against the real drug to see if the active medicine truly makes a difference.

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

No, neither you nor your doctor will know whether you are receiving safinamide or the placebo during the study. This helps ensure the study results are fair and unbiased.

How long will I be involved in the study?

If you join, your active participation in the study will last for 12 weeks, during which you will take the study medication and attend regular appointments.

Why is this study important?

This study is important because it could help find new ways to manage pain for people with Parkinson's disease, especially those who experience motor fluctuations, potentially improving their quality of life.