A multicenter, open-label, single-arm study to evaluate long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy
This clinical trial is researching a medicine named brivaracetam to see if it is safe and well-tolerated over a longer period. It focuses on adults aged 18 and older who have childhood absence epilepsy or juvenile absence epilepsy. These conditions cause brief lapses in awareness, often described as blank spells or staring into space. In this study, there is no dummy pill (placebo). Every participant receives brivaracetam. Doctors will closely track any unwanted side effects and check how comfortable people feel taking the treatment over time. This helps researchers discover whether the medicine could be a safe, practical long-term treatment option for adults managing absence seizures. Taking part is completely voluntary, and you can leave the study at any time without your regular NHS care being affected.
At a glance
What is this study about?
Absence epilepsy is a brain condition where a person experiences sudden, brief pauses in attention. During a seizure, someone might look like they are daydreaming or staring blankly for a few seconds before returning to what they were doing. While these seizures usually start in childhood or teenage years, some people continue to have them as adults. Finding reliable, gentle treatments is important to help people manage their symptoms and get on with daily life.
This clinical trial is investigating an anti-seizure medicine called brivaracetam. Brivaracetam is already prescribed for certain other types of epilepsy, but doctors want to understand how safe and comfortable it is for people with absence epilepsy when taken over a longer period. The main focus is to watch for any side effects and learn how well the body handles the medicine.
Because this is an "open-label" trial, everyone who takes part will receive the active study medicine. There is no dummy pill (placebo). The results will help researchers determine whether brivaracetam could become a trusted long-term option for adults living with absence seizures.
Key takeaways
- Tests the long-term safety and tolerability of the epilepsy medicine brivaracetam.
- Open to adults aged 18 and older with childhood or juvenile absence epilepsy.
- All participants receive the study medicine; there is no dummy pill (placebo).
- Involves regular health checks and close monitoring by epilepsy specialists.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with either childhood absence epilepsy or juvenile absence epilepsy. Both men and women can take part.
To be eligible, you need to be generally well enough to follow the study routine and attend regular check-ups. Because the trial is testing brivaracetam, doctors will check that it is safe for you to take based on your current health and medical history.
You may not be able to join if you have certain other serious health issues, or if you have had severe allergic reactions to similar epilepsy medicines in the past. The study team will carefully review your details to make sure joining is safe 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.
- I am aged 18 or older.
- I have been diagnosed with childhood absence epilepsy or juvenile absence epilepsy.
- I am able and willing to attend regular clinic appointments.
- I am happy to take the trial medicine as instructed by the doctors.
What does participation involve?
If you decide to take part, you will be prescribed brivaracetam to take as directed by the study doctors. You will visit a study clinic or hospital regularly so the team can monitor your health. During these appointments, doctors may check your blood pressure, run routine blood tests, and ask you how you are feeling and whether you have noticed any side effects. You will also be asked about your seizures. The trial team will explain the full schedule of visits, how long the study will last, and what to expect before you agree to begin.
Potential risks and benefits
Locations (4)
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedSpain
- —UnverifiedSlovakia
Common questions
What is absence epilepsy?
It is a form of epilepsy that causes brief, sudden pauses in awareness. To others, it can look like the person is daydreaming or staring blankly for a few seconds.
Will I be given a dummy pill (placebo)?
No. This is an open-label study, meaning every person who takes part receives the active medicine, brivaracetam.
How does brivaracetam work?
Brivaracetam is an anti-seizure medicine designed to calm unusual bursts of electrical activity in the brain that cause seizures.
Do I have to pay to take part?
No. Clinical trial medication and study-related health checks are free. Many trials also help cover travel costs to and from hospital visits.
Can I leave the study if I change my mind?
Yes. You can stop taking part at any time. Your decision will not change your relationship with your regular doctors or your normal NHS treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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