Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2-Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

This research study is investigating a drug called brivaracetam for children and young adults aged 2 to 25 who have either Childhood Absence Epilepsy or Juvenile Absence Epilepsy. These are types of epilepsy where a person might have brief moments of staring, called absence seizures. The study aims to find the best dose of brivaracetam, check if it effectively reduces or stops these seizures, and make sure it's safe to use. Some participants will receive the actual medicine, while others will get a placebo (a pill with no active drug) to help researchers understand the medicine's true effects. The main goal is to see how many people become free from absence seizures, especially after a couple of weeks, using brain wave tests (EEG) and diaries.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

UCB Biopharma

Enrolment target

107

Start

21 May 2024

Childhood Absence Epilepsy Juvenile Absence Epilepsy

What is this study about?

This study is focusing on a specific type of epilepsy called absence epilepsy, which affects children and young people. There are two main kinds being looked at here: Childhood Absence Epilepsy and Juvenile Absence Epilepsy. Both involve short periods where a person might seem to 'switch off' or stare blankly – these are called absence seizures. The researchers want to find out if a medicine called brivaracetam can help reduce or stop these seizures in people aged 2 to 25.

To do this, they are conducting a careful study. Some participants will receive brivaracetam, and others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This is a very common and important way that scientists can tell if the medicine itself is actually working, or if improvements might be due to other factors. The study will also try to figure out the best dose of brivaracetam to use.

Over several weeks, the research team will closely monitor participants. They'll use special brain wave tests called EEGs (electroencephalograms) to record brain activity and look for seizures. Participants and their families will also keep diaries to note any seizures. The main thing they want to find out is how many people become free from absence seizures within a couple of weeks of starting treatment, and if the medicine is safe and well-tolerated.

Key takeaways

This study is testing a promising new medicine called brivaracetam for absence epilepsy.
It's for children and young people aged 2 to 25 with Childhood Absence Epilepsy or Juvenile Absence Epilepsy.
The study compares brivaracetam to a dummy pill (placebo) to see if it effectively reduces seizures.
Participating involves taking the medicine, regular doctor visits, keeping seizure diaries, and brain wave tests (EEGs).
The main goal is to find out if the medicine helps people become seizure-free and if it's safe.
You can discuss this study with your doctor to see if it might be right for you or your child.

Who may be eligible?

This study is designed for children and young adults. To be considered, you need to be between 2 and 25 years old. The researchers are looking for people within this age range.

Importantly, participants must have been diagnosed with either Childhood Absence Epilepsy or Juvenile Absence Epilepsy. These are specific types of epilepsy that involve brief 'absence seizures' where a person might stare or seem to 'switch off' for a short time.

Both boys and girls, men and women, are eligible to take part in this research if they meet the age and epilepsy type criteria. The study will assess other health factors to ensure it's suitable and safe for everyone involved.

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 or the person considering the study between 2 and 25 years old?
Have you or the person been diagnosed with Childhood Absence Epilepsy?
OR have you or the person been diagnosed with Juvenile Absence Epilepsy?
Are you able to attend regular clinic appointments and follow study instructions?
Are you willing to potentially receive either the study drug or a placebo?
Do you want to contribute to research in epilepsy?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have health checks to make sure it's safe and suitable for you. Then, you would be given either the study medicine, brivaracetam, or a placebo (a dummy pill with no active ingredient). Neither you nor your doctor would know which one you're receiving – this is called 'double-blind' and helps make the study fair.

You would need to take the medicine regularly as instructed. There would be several visits to the study clinic where doctors and nurses would check your health, ask about your seizures, and perform special brain tests called EEGs (electroencephalograms). Some of these EEGs might involve wearing a small device for 24 hours to record brain activity at home. You or your caregiver would also keep a diary to track any seizures.

After a certain period, some participants might enter a 'randomized withdrawal' phase, where they might be switched to a different treatment plan under close medical supervision. The total length of your participation would be explained to you, but it would involve regular check-ups and follow-up to monitor your seizures and any side effects. You can withdraw from the study at any time.

Potential risks and benefits

Taking part in a clinical trial offers the chance to try a new medicine that might help manage your epilepsy. It also contributes to medical knowledge, which could help many other people in the future. However, like all medicines, brivaracetam could have side effects, and some people in the study will be given a placebo and might not experience any direct benefit from the drug. The research team will carefully monitor your health throughout the study to identify any unwanted effects. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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
Slovakia
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Unverified
Romania
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Unverified
Italy

Common questions

What is 'absence epilepsy'?

Absence epilepsy causes short periods where a person stops what they're doing, stares blankly, and seems to 'switch off' for a few seconds. These are called absence seizures.

What is brivaracetam?

Brivaracetam is a medicine that is being studied to see if it can help control seizures in people with epilepsy.

What is a 'placebo'?

A placebo looks like the real medicine but doesn't contain any active drug. It helps researchers find out if the medicine itself is actually working.

What is an EEG?

An EEG (electroencephalogram) is a safe and painless test that records the electrical activity in your brain. It helps doctors see if there are any signs of seizures.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and it won't affect your regular medical care.