Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

This study is a long-term look at the safety of a medicine named cenobamate. It's for adults (18 years and older) who experience a specific kind of seizure, known as primary generalized tonic-clonic seizures. These are seizures that affect the whole body. The main goal of the study is to carefully monitor for any side effects or health changes that might occur when people take cenobamate for a longer period. Researchers will be checking things like regular blood tests, vital signs (like blood pressure), and physical examinations. This is a follow-up study, meaning participants have likely taken cenobamate before, and now researchers want to understand its ongoing safety as an add-on treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sk Life Science Inc.

Enrolment target

Start

10 May 2024

Primary Generalized Tonic-Clonic Seizures

What is this study about?

This study is about a medicine called cenobamate, which is used to help people who have a specific type of seizure. These seizures are known as primary generalized tonic-clonic seizures, and they affect the whole body. The main purpose of this research is to understand the long-term safety of cenobamate when it's used alongside other seizure medicines, which is called 'adjunctive therapy'. This is an 'open-label extension study', meaning participants will know they are receiving cenobamate, and it's a continuation for people who have already been taking it in a previous study.

Think of it like this: after a new car is first sold, engineers still keep a close eye on how previous models perform over many years to make sure they are safe and reliable in the long run. In the same way, researchers want to see how patients' health changes over an extended period while taking cenobamate. They will be carefully checking for any side effects or unexpected health problems. This is really important to make sure the medicine is safe for people to use for a long time.

The information gathered from this study will help doctors and patients understand cenobamate better, especially its long-term effects. This type of research, known as 'Phase III' in medical studies, is a big step towards confirming if a new treatment is effective and safe enough for wider use. By checking things like blood tests, heart readings (ECGs), and physical checks, the researchers aim to get a full picture of the medicine's safety profile.

Key takeaways

This study evaluates the long-term safety of cenobamate for a type of seizure called primary generalized tonic-clonic seizures.
It's for adults (18 years and older) who are already taking cenobamate as part of a previous study.
The main focus is to carefully monitor for any side effects or health changes over time.
Participants will have regular medical check-ups, including blood tests, vital signs, and heart scans.
This research helps doctors and patients understand the ongoing safety of cenobamate.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. Both men and women can take part.

You must have primary generalized tonic-clonic seizures, which are seizures that affect your whole body. This study is specifically for people who have already been taking cenobamate as part of a previous study. It's designed to continue monitoring your health while you carry on with the treatment.

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 primary generalized tonic-clonic seizures?
Have you previously taken cenobamate as part of another study?
Are you able to attend regular appointments for health check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be continuing to receive cenobamate as an add-on treatment for your seizures. Researchers will carefully check your health at regular visits. These checks will include various assessments to monitor your safety. You will likely have physical examinations, where a doctor checks your general health, and neurological examinations, which focus on your brain and nervous system.

You'll also have regular blood tests to check how your body is responding to the medicine and to look for any changes in your blood. Your vital signs, such as blood pressure and heart rate, will be measured, and you'll have an electrocardiogram (ECG) to check your heart health. The total duration of your participation will depend on the study design for this long-term extension, continuing for as long as deemed necessary to gather sufficient safety data.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of continuing in this study is that it allows you to keep receiving cenobamate, which might be helping to control your seizures. You will also receive very close medical attention and monitoring from the study team, which could spot any health changes early. As for risks, while cenobamate is being monitored for safety, there's always a chance of experiencing side effects, some of which might be serious. The study team will explain all known potential side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

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Unverified
Germany
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Unverified
Hungary
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Unverified
Spain
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Unverified
Slovakia
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Unverified
Poland

Common questions

What kind of seizures is this study for?

This study is for adults who experience primary generalized tonic-clonic seizures, which are seizures that affect the entire body.

What is cenobamate?

Cenobamate is a medicine being studied as an additional treatment to help control seizures.

Why is this study important?

This study is important because it will help us understand the long-term safety of cenobamate when used as an add-on treatment for seizures, which is crucial for patient care.

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

Yes, this is an 'open-label' study, which means you and the study doctors will know that you are receiving cenobamate.

What will researchers be checking during the study?

Researchers will mainly be checking your safety through physical exams, neurological exams, blood tests, vital signs, and heart readings (ECGs) to look for any side effects.