A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults with Focal Seizures (POWER 1)
This research, called POWER 1, is a study to find out if a new medicine, PRAX-628, can help adults who have focal seizures. Focal seizures start in one part of the brain. The study will compare PRAX-628 to a 'dummy pill' (placebo) to see if it reduces how often people have seizures and if it's safe to use. Half the participants will get the new medicine, and the other half will get the dummy pill, but no one will know which they are taking until the study is over. This is to make sure the results are fair and accurate. The study is hoping to see if PRAX-628 can make a real difference in controlling seizures for those living with focal epilepsy.
At a glance
What is this study about?
This study, known as POWER 1, is designed to test a new medicine called PRAX-628 for adults who experience focal seizures. Focal seizures are a type of epilepsy where the electrical disturbance begins in a specific area of the brain. The main goal of this study is to see how well PRAX-628 works compared to a 'dummy pill' (placebo) in reducing the number of focal seizures people have each month. Researchers also want to make sure the new medicine is safe and to understand any side effects it might have.
To make sure the results are fair and unbiased, the study uses a 'double-blind, randomised' approach. This means that participants will be randomly assigned to either receive PRAX-628 or the placebo, and neither the participants nor their doctors will know which treatment they are getting. This helps in understanding the true effect of the new medicine. The study will carefully track changes in seizure frequency over time, measure how many people have their seizures cut by half (or even become seizure-free), and monitor general well-being and any changes in health.
By comparing PRAX-628 to a placebo, the researchers can determine if the new medicine is truly effective in reducing seizures and improving the lives of people with focal epilepsy. This type of research is crucial for developing new treatments and providing more options for managing this condition. Understanding both the benefits and potential risks of PRAX-628 will help medical professionals decide if it could be a valuable addition to epilepsy treatment.
Key takeaways
- The study is testing a new medicine (PRAX-628) for adults with focal epilepsy.
- It aims to see if PRAX-628 reduces seizures compared to a dummy pill.
- Participation involves regular clinic visits, assessments, and taking study medication.
- Both treatment groups (PRAX-628 and dummy pill) receive close medical monitoring.
- You can stop participating at any time.
- The goal is to find effective and safe new treatments for focal epilepsy.
Who may be eligible?
This study is looking for adults aged 18 years and older who have been diagnosed with focal epilepsy. Both men and women are welcome to participate.
Beyond the basic age and diagnosis requirements, there will be other specific health checks and medical history questions to ensure the study is safe and appropriate for you. For instance, doctors will need to review your current epilepsy treatment, other health conditions you might have, and any other medications you are taking.
It's important to discuss your full medical history with the study team. They will carefully assess whether this study is the right fit for you and answer any questions you might have about taking part.
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?
- Have you been diagnosed with focal epilepsy?
- Are you able to attend regular clinic appointments?
- Are you willing to potentially take a new, unapproved medication or a dummy pill?
- Are you able to keep a record of your seizures?
- Are you currently receiving treatment for focal epilepsy?
What does participation involve?
If you decide to take part in this study, you will have several visits to the clinic. At the beginning, you will have a 'screening period' which involves checks to see if you are suitable for the study. After this, you will enter the 'treatment period' where you will regularly take either the new medicine, PRAX-628, or a dummy pill (placebo).
You will have regular appointments where study doctors and nurses will monitor your health, take vital signs (like blood pressure), collect blood samples, and perform ECGs (heart tracings). You'll also be asked questions about your seizures and how you are feeling, including any side effects. You will need to keep a diary of your seizures. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is focal epilepsy?
Focal epilepsy means that your seizures start in a specific area of your brain, rather than affecting your whole brain at once.
What is a 'dummy pill' or placebo?
A dummy pill (placebo) looks exactly like the study medicine but contains no active drug. It helps researchers check if the new medicine really works better than no treatment.
What does 'double-blind' mean?
Double-blind means that neither you nor the doctors treating you will know if you are receiving the new medicine or the dummy pill. This helps keep the study fair.
How long will I be in the study?
The exact length of time will be discussed with you by the study team, as it includes a screening period, a treatment period, and follow-up.
Can I leave the study at any time?
Yes, you have the right to leave the study at any point, for any reason, without affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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