A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
This research study is looking at a new medicine called cenobamate for people who experience Primary Generalized Tonic-Clonic seizures. These are a particular kind of seizure that affects the whole brain. The study aims to find out if cenobamate can reduce how often these seizures happen and to check for any side effects. Participants will receive either different doses of cenobamate or a dummy pill (placebo). It's a 'double-blind' study, meaning neither the patient nor the doctor will know who is getting the active medicine. This helps ensure fair and accurate results. The study compares the new medicine to the placebo to understand its benefits and risks.
At a glance
What is this study about?
You might be interested in this study if you or someone you know has Primary Generalized Tonic-Clonic seizures. These are seizures that affect the entire brain and body. Doctors are always looking for better ways to help people manage their seizures, and this study is testing a new medicine called cenobamate to see if it can help reduce how often these specific seizures occur and if it's safe.
The study is designed to be very thorough. Some people will receive different strengths of cenobamate, while others will get a 'placebo' – which looks exactly like the study medicine but contains no active drug. This is common in research and helps doctors understand if the new medicine is truly effective or if improvements might be due to other factors. Since neither you nor your doctor will know if you're getting cenobamate or the placebo, this helps keep the study unbiased and ensures the results are as reliable as possible.
The main goal is to see if cenobamate can significantly lower the number of Primary Generalized Tonic-Clonic seizures people have. They'll also be carefully looking at any side effects to make sure the medicine is safe. The results of this study will help decide if cenobamate can become a new treatment option for people with this type of epilepsy.
Key takeaways
- Tests a new medicine (cenobamate) for specific seizures.
- Aims to reduce seizure frequency and check safety.
- Involves some participants receiving a harmless dummy pill (placebo).
- Neither you nor your doctor will know which treatment you receive.
- Designed for people aged 18 and older with Primary Generalized Tonic-Clonic seizures.
- Participation includes regular health checks and monitoring.
Who may be eligible?
To be part of this study, you need to be at least 18 years old – there's no upper age limit. Both men and women are welcome to take part.
However, there are other important things that the study doctors will check to make sure the study is right for you. They will need to confirm you have Primary Generalized Tonic-Clonic seizures and that your overall health allows you to safely participate.
It's important to discuss your full medical history with the study team. They will be able to tell you if you meet all the necessary criteria to join.
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 Primary Generalized Tonic-Clonic seizures?
- Are you willing to attend regular clinic visits?
- Are you comfortable with the possibility of receiving a placebo?
- Are you willing to discuss your full medical history with the study team?
- Are you available for the full duration of the study (to be clarified by the team)?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to one of several groups. Some groups will receive different dose strengths of the study medicine, cenobamate, and others will receive a 'placebo' (a dummy pill with no active medicine).
Your participation will involve regular visits to the study clinic where doctors and nurses will monitor your health and how you're responding to the treatment. This will include keeping track of your seizures, blood tests, checks of your heart (ECG), physical exams, and neurological exams. You'll also be asked about any side effects you might experience. These visits are spread out over a specific period, and there will be follow-up appointments after you finish taking the study medicine. The total duration of your participation, including treatment and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedSlovakia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedPoland
- —UnverifiedGermany
Common questions
What kind of seizures is this study for?
This study is specifically for people who experience Primary Generalized Tonic-Clonic seizures, which involve the whole brain.
What is cenobamate?
Cenobamate is the new medicine being tested in this study to see if it can help reduce the frequency of this specific type of seizure.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the study medicine but doesn't contain any active drug. It helps compare the real medicine's effects.
Will I know if I'm getting the medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you're receiving cenobamate or the placebo until after the study ends.
How long will I be in the study?
The full duration of your participation, including the treatment period and any follow-up, will be explained in detail by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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