Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson’s Disease

This research study is looking at a new medication called suvecaltamide. It's for people living with Parkinson's disease who experience moderate to severe tremors, which is shaking that affects everyday activities. For 17 weeks, participants will either take the new medicine or a placebo (a dummy pill with no active ingredient) once a day. The main goal is to find out if suvecaltamide can help improve these tremors and make daily life easier, and also to check if it's safe and causes any side effects. This is a Phase 2 study, meaning it's an earlier stage where researchers are exploring how well the treatment works and what its potential side effects might be.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cavion Inc.

Enrolment target

132

Start

10 Oct 2024

Parkinson's Disease

What is this study about?

This study is trying to find out if a new medicine, called suvecaltamide, can help people with Parkinson's disease who have bothersome shaking, known as tremor. Tremor can make everyday tasks like eating, writing, or dressing more difficult. Researchers want to see if taking this medicine once a day for 17 weeks can reduce these tremors and improve how people perform daily activities.

To do this, some participants will receive the active medicine, suvecaltamide, while others will receive a 'dummy' pill called a placebo. Neither the participants nor their doctors will know who is getting which, which helps to ensure the results are as fair as possible. This is a common way to test new medicines and find out if they truly work better than no treatment.

The study will also carefully check for any side effects or unwanted reactions to the medicine. Researchers will monitor participants' overall health through various tests. This information is crucial for understanding if suvecaltamide is both effective and safe for people with Parkinson's disease.

Key takeaways

This study tests a new medicine (suvecaltamide) for Parkinson's tremor.
It lasts for 17 weeks and involves taking a tablet once a day.
You might receive the active medicine or a placebo (dummy pill).
Doctors will check if the medicine helps your tremor and if it's safe.
It's for adults (18+) with moderate to severe Parkinson's tremor.

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.

The main requirement is that you have Parkinson's disease and experience tremors that are moderate to severe. This means the shaking is noticeable and affects your ability to do things in your daily life. The doctors involved in the study will confirm if your tremors meet these specific criteria.

There might be other health conditions or medications that would prevent you from taking part, but the research team will discuss all these details with you to make sure the study is a safe and suitable option for you.

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 moderate to severe tremors that affect your daily activities?
Are you able to attend regular clinic visits for about 17 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will last for 17 weeks, which is about four months. During this time, you will take either the study medicine (suvecaltamide) or a placebo (a dummy pill) once a day. You won't know which one you're taking.

You'll have several visits to the study clinic where doctors and nurses will check your health, measure your tremor, and see how well you're doing everyday tasks. They will also ask you to complete questionnaires about your tremors and how they affect you. You'll have regular health checks, including blood tests, measurements of your blood pressure and heart rate, and possibly heart rhythm tests (ECGs), to make sure the medicine is safe for you. The research team will explain all visits and assessments in detail before you make your decision.

Potential risks and benefits

Participating in this study might offer a potential benefit if you receive the active medicine and it helps to reduce your tremors and improve your daily activities. However, there's also a chance you might receive the placebo and experience no direct benefit from the study drug. All medicines carry potential risks, and you might experience side effects from suvecaltamide, or from any procedures involved in the study; these will be carefully monitored. 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
Germany
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Unverified
Poland

Common questions

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active ingredient. It helps researchers see if the actual medicine truly works better than taking nothing at all.

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

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is to ensure the study results are fair and unbiased.

How long will I take the study medicine?

You will take the study medicine or placebo once daily for 17 weeks, which is about four months.

What will happen if my tremor gets worse during the study?

Your health and tremor will be regularly monitored by the study team. If your tremor or any other health issue worsens, the study team will discuss appropriate medical care with you, and you can withdraw from the study at any time.

What are 'Phase 2' studies?

Phase 2 studies are an earlier stage of drug development. They explore how well a new treatment works, what the right dose might be, and what its potential side effects are, in a larger group of people than Phase 1 studies.