Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Single-Blind, Placebo-Controlled, Fixed-Sequence Design Trial to Evaluate the Photoparoxysmal Electroencephalogram Response, Safety, Tolerability, and Pharmacokinetics of PRAX-628 in Participants with Epilepsy and a Photoparoxysmal Electroencephalogram Response to Intermittent Photic Stimulation

This study is looking into a new medicine called PRAX-628 for individuals who have epilepsy and experience specific electrical changes in their brain when exposed to flashing lights. This is a "Phase 2" study, meaning we're trying to understand if the medicine works and is safe. Some participants will receive PRAX-628, while others will get a placebo (a dummy medicine to compare against). We'll be closely monitoring how the medicine affects the brain's response to flashing lights, how much of it stays in the body, and any side effects. The main goal is to see if PRAX-628 can reduce or stop the brain's unusual reaction to these flashing lights.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Praxis Precision Medicines Inc.

Enrolment target

Start

09 Jun 2023

IPS induced photoparoxysmal electroencephalogram response (IPS-induced PPR) in participants with epilepsy and IPS-induced PPR

What is this study about?

Imagine your brain is like a complex electrical system. For some people with epilepsy, certain flashing lights can cause particular electrical patterns in their brain that might lead to a seizure. This study is testing a new medicine, PRAX-628, to see if it can help stop these electrical patterns from happening when exposed to flashing lights.

This is a 'Phase 2' study. This means we're still in the early stages of testing this medicine. We want to find out how well PRAX-628 works, how much of it stays in your body after you take it, and importantly, if it is safe for people to use. We're hoping it can calm down those specific brain reactions to flashing lights.

To understand if the medicine is working, some people will get PRAX-628, and others will get a placebo. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps us compare the effects and make sure any changes we see are truly due to PRAX-628. We'll be checking your brain's response to flashing lights, taking blood samples to see how the medicine moves through your body, and carefully looking for any side effects.

Key takeaways

This study is for adults with epilepsy whose brains react to flashing lights.
It's testing a new medicine called PRAX-628 to see if it can stop these brain reactions.
Some participants will receive the active medicine, others a placebo.
Your brain activity, blood levels of the medicine, and side effects will be closely checked.
The main aim is to find out if PRAX-628 is effective and safe.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

A key requirement is that you must have epilepsy and experience a specific brain reaction to flashing lights. This reaction is something doctors can see during a test called an electroencephalogram (EEG) where they watch your brain activity while you're exposed to flashing lights. If your brain shows this particular response, you might be suitable for the study.

There might be other health conditions or medicines that mean you can't join, but these will be discussed in detail by the study team during the screening process.

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?
Do you have epilepsy?
Has a doctor told you that your brain shows a specific reaction to flashing lights (an IPS-induced PPR)?
Are you able to attend regular appointments for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine, PRAX-628, or a placebo, which looks the same but contains no active drug. This will be done in a set order over several visits. You won't know if you're getting the active medicine or the placebo, and neither will the study team in some parts of the study. This helps us get fair and unbiased results.

You'll have regular appointments where doctors will check your health. This will include tests like an EEG with flashing lights to see how your brain responds, blood tests to measure the medicine in your system, and checks of your heart and general well-being. The study team will explain everything in detail, including how long each visit will be and the total duration of your involvement.

Potential risks and benefits

Taking part in this study may offer a chance to try a new medicine that could potentially help reduce your brain's reaction to flashing lights, which might be helpful for your epilepsy. However, there's also the chance that the medicine may not work for you, or you might receive the placebo. Like all medicines, PRAX-628 may have side effects, and we will closely monitor you for any. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is 'photoparoxysmal electroencephalogram response'?

It's a specific pattern seen on a brain scan (EEG) in some people with epilepsy when they are exposed to flashing lights, which means their brain reacts unusually to these lights.

What does 'placebo-controlled' mean?

It means some people will get the active medicine, and some will get a dummy medicine (a placebo) that looks the same. This helps us compare the effects fairly.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know, and often the study team won't know either. This is called 'single-blind' and helps ensure the results are unbiased.

What is a 'Phase 2' study?

It means this is an early stage of testing a new medicine. We are trying to find out if it works, how much of it to use, and if it's safe.

How long will I have to be involved in the study?

The study team will explain the exact duration during your initial discussions, including the number and length of visits.