Efficacy of prophylactic levetiracetam for improving functional outcome in the acute phase of intracerebral haemorrhage: a randomised, double-blind, placebo-controlled, phase 3 trial PEACH 2
This study, called PEACH 2, is investigating if a common medication called levetiracetam (known as Keppra) can help people who have had a brain bleed, also called an intracerebral haemorrhage. We want to see if taking this medication can improve their recovery and their ability to live independently after six months. Participants will either receive levetiracetam or a dummy treatment (placebo). Neither the patient nor their doctors will know which treatment they are getting. We'll carefully check their health, how well they can do everyday tasks, their thinking skills, and their quality of life up to a year later. We're also looking for any side effects. This research aims to find better ways to help people recover after a brain bleed.
At a glance
What is this study about?
Imagine you've had a brain bleed, also known as an intracerebral haemorrhage – it's a serious condition that can affect how well your brain works and how you live your life afterwards. This study, called PEACH 2, is designed to see if a medication called levetiracetam (you might know it as Keppra) can help people recover better from this type of event. Sometimes, after a brain bleed, people can experience problems with brain function, and we want to know if this drug can reduce those issues.
In this study, we're comparing levetiracetam with a 'placebo' which looks just like the real drug but contains no active medicine. This is a standard way to test if a drug truly works. Neither you nor your doctor will know if you're getting the actual drug or the placebo, which helps us get unbiased results. We'll be closely monitoring your progress for up to a year to understand if the medication helps with your overall recovery, including how well you can go about your daily life, your thinking abilities, and your general well-being.
We will be looking at several things, such as how independent you are six months after the brain bleed, if you have any seizures, changes in your physical abilities, your memory and thinking skills, and your quality of life. We'll also keep a close eye on any side effects you might experience. The goal of this research is to find out if levetiracetam can make a real difference in helping people recover more fully after a brain bleed, potentially leading to better treatments in the future.
Key takeaways
- The study tests if levetiracetam (Keppra) helps recovery after a brain bleed.
- It compares the drug to a dummy treatment (placebo) for fairness.
- Researchers will check physical recovery, thinking skills, and quality of life.
- You would be followed for about one year.
- The study aims to find better ways to help people recover from brain bleeds.
Who may be eligible?
To be able to join this study, you would need to be 18 years old or older. The study is open to both men and women.
There might be other specific health reasons that mean you can or cannot take part, but these are the main general requirements. The doctors running the study will check if you meet all the necessary criteria to ensure the study is safe and effective for everyone involved.
- Are you 18 years old or older?
- Have you recently had a brain bleed (intracerebral haemorrhage)?
- Are you willing to potentially receive either the study drug or a placebo?
- Are you able to attend follow-up appointments for up to one year?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would either receive the study medication (levetiracetam) or a dummy treatment (placebo). This medication could be given as tablets or through a drip into your arm initially. Neither you nor your doctors will know which one you are receiving during the study.
You would have several follow-up appointments. At these visits, doctors or specially trained research staff will ask you questions about your health, perform assessments to check your physical abilities, thinking skills, and overall well-being. Some of these checks might happen in person, or if needed, remotely (like over the phone or video call).
These checks will happen at various times, including shortly after joining the study, and then at 1 month, 6 months, and 12 months (one year) after your brain bleed. The total time you would be involved in the study, including all follow-up assessments, would be about one year.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is an intracerebral haemorrhage?
It's a type of stroke where bleeding occurs inside the brain, which can damage brain cells.
What is levetiracetam (Keppra) currently used for?
It's a medication commonly used to treat epilepsy, a condition that causes seizures.
What does 'double-blind' mean in a study?
It means neither the patient nor their doctors know if they are receiving the real medication or a dummy treatment, to keep the results fair and unbiased.
How long will I be involved in the study?
If you join, you would be followed for about one year after your brain bleed.
Will I still receive my usual medical care?
Yes, taking part in the study will not stop you from receiving the standard medical care needed for your condition.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.