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Study of Suvecaltamide for Treating Moderate to Severe Tremor in Parkinson's Disease Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Parkinson's Disease, a condition that affects movement and can cause tremors. The study is testing a new treatment called Suvecaltamide, which is taken as a prolonged-release capsule. The purpose of the study is to see if Suvecaltamide can help reduce moderate to severe tremors in people with Parkinson's Disease.

Participants in the study will be randomly assigned to receive either Suvecaltamide or a placebo, which looks like the real medication but does not contain the active ingredient. The study will last for 17 weeks, during which participants will take the medication once daily. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, the safety and effectiveness of Suvecaltamide will be closely monitored. Participants will have regular check-ups to assess any changes in their tremor symptoms and overall health. The goal is to determine if Suvecaltamide can improve the daily functioning and quality of life for those experiencing tremors due to Parkinson's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility for the trial will be confirmed. This includes checking your medical history and current health status.
You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks.
Step 2
Baseline assessment
A baseline assessment will be conducted to evaluate your current condition. This involves various tests and evaluations to measure the severity of your tremor and other symptoms related to Parkinson's disease.
These assessments will help in comparing your condition before and after the treatment.
Step 3
Treatment phase
You will begin the treatment phase, which lasts for 17 weeks. During this time, you will take a medication called suvecaltamide once daily. This medication is provided in the form of a prolonged-release capsule, which means it releases the active substance slowly over time.
The dosage may be adjusted based on your response to the treatment. You will also continue any other Parkinson's disease medications you are currently taking, as long as they have been stable for at least 6 weeks prior to the study.
Step 4
Regular follow-up visits
Throughout the treatment phase, you will have regular follow-up visits. These visits are important for monitoring your progress and any side effects you may experience.
During these visits, your tremor and other symptoms will be evaluated, and any necessary adjustments to your treatment will be discussed.
Step 5
Final assessment
At the end of the 17-week treatment period, a final assessment will be conducted. This will involve similar tests and evaluations as the baseline assessment to measure any changes in your condition.
The results of this assessment will help determine the effectiveness of the treatment.

Who can join the trial?

10 criteria

Participants must be between 40 and 85 years old at the time of signing the consent form.
Participants must have a body mass index (BMI) between 17 and 45. BMI is a measure of body fat based on height and weight.
Participants must have a diagnosis of Parkinson's Disease that meets specific criteria established in 2015, diagnosed within the past 5 years.
Participants must be on the best possible treatment for other Parkinson's symptoms like slow movement and stiffness, as determined by the study doctor.
Participants must be on a stable dose of their Parkinson's or tremor medications for at least 6 weeks before the study starts and should not expect to change this during the study.
If participants experience changes in their symptoms, their tremor must be present during periods when their medication is working, and they should be able to have their tremor evaluated during these times.
Participants must have moderate to severe tremor at both the initial screening and the start of the study.
Participants must agree to use contraception during the study and for at least 30 days after the last dose if they are male, or if female, they must not be pregnant or breastfeeding and must comply with specific contraceptive conditions.
Participants must be capable of giving informed consent, which means they understand the study and agree to follow its requirements and restrictions.
Participants must be willing and able to follow the study schedule and other requirements.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of Parkinson's Disease cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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Cracow, Poland
Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain
Hospital Universitario De La Princesa
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Madrid, Spain

Trial locations

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Investigated drugs

Suvecaltamide is a medication being studied for its potential to help people with Parkinson's Disease who experience moderate to severe tremors. Tremors are involuntary shaking movements that can make daily activities difficult. This medication is taken once a day and is being tested to see if it can reduce these tremors, helping improve the ability to perform everyday tasks. The study aims to find out if suvecaltamide can make a noticeable difference in the lives of people dealing with these challenging symptoms.

Suvecaltamide

What is already known about the treatment

Suvecaltamide – Suvecaltamide is taken as a pill once a day and is currently being studied in clinical trials to see how well it works and how safe it is for people with Parkinson's Disease who have moderate to severe tremors. This medication is not yet widely used in medicine, as it is still being researched. It is intended to help reduce the shaking that people with Parkinson's Disease experience, which can make daily activities difficult. Suvecaltamide works by affecting certain chemicals in the brain that are involved in controlling movement, and it is classified as a type of drug that targets these brain chemicals to help manage symptoms.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with a barely noticeable tremor in one hand. As it advances, individuals may experience slower movement, muscle rigidity, and impaired posture. Over time, the symptoms can become more pronounced, affecting daily activities and leading to challenges in walking and speaking. The progression of Parkinson's Disease varies among individuals, with some experiencing more rapid changes than others.