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A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a new treatment called PRAX-628 for individuals with epilepsy. Epilepsy is a condition that affects the brain and causes repeated seizures. The study specifically looks at a type of brain response called the photoparoxysmal electroencephalogram (EEG) response, which can occur in people with epilepsy when they are exposed to flashing lights. The purpose of the study is to evaluate how PRAX-628 affects this brain response compared to a placebo.
Participants in the study will receive PRAX-628 in the form of a capsule taken by mouth. The study will follow a fixed sequence design, meaning that participants will receive the treatment in a specific order. The trial will assess the safety and tolerability of PRAX-628, which means checking for any side effects and how well participants can handle the treatment. Additionally, the study will measure the levels of PRAX-628 in the blood to understand how the body processes the medication.
The trial will also monitor changes in vital signs, such as heart rate and blood pressure, as well as any changes in laboratory test results and heart activity measured by an electrocardiogram (ECG). The goal is to see if PRAX-628 can reduce or eliminate the photoparoxysmal EEG response in participants with epilepsy. This study is important for understanding the potential benefits and risks of PRAX-628 as a treatment option for epilepsy.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
8 criteria
3 criteria
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PRAX-628 is a medication being studied for its effects on people with epilepsy. In this trial, researchers are looking at how PRAX-628 affects brain activity in response to flashing lights, which can sometimes trigger seizures in people with epilepsy. The study aims to see if PRAX-628 can help reduce these brain responses and improve safety and tolerability for the participants. The medication is also being evaluated to understand how it moves through and is processed by the body, which is known as pharmacokinetics.
Other trials in this disease – keep exploring while you decide
The Netherlands
France
PolandPolandThe Netherlands
Belgiumsourced from the EU Clinical Trials Register and site verification
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