Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients with Focal Onset or Primary Generalized Tonic-Clonic Seizures

This study is looking into a new medicine called PRAX-628 for adults who experience specific types of seizures. These include focal onset seizures, which start in one part of the brain, or primary generalized tonic-clonic seizures, which affect the whole brain. The main goal is to find out how much PRAX-628 can reduce the number of seizures a person has each month and to check for any side effects. It's a Phase II trial, meaning it's still in the early stages of testing, where researchers are exploring if the medicine works and if it's safe enough to continue with larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Praxis Precision Medicines Inc.

Enrolment target

Start

14 Feb 2025

Focal onset seizures or primary generalized tonic-clonic seizures

What is this study about?

This clinical trial is designed to see if a new medicine called PRAX-628 can help people who have certain types of seizures. These include 'focal onset seizures', which begin in a specific area of the brain, and 'primary generalized tonic-clonic seizures', which are the classic 'grand mal' seizures affecting the entire brain. The researchers want to find out how effective this new medicine is at reducing the number of seizures a person has every month. They will also be closely watching for any side effects to make sure it's safe.

The study involves comparing seizure numbers before and after taking PRAX-628. They'll be looking at the average change in monthly seizure frequency, as well as how many people have their seizures cut in half, or even become seizure-free. This is an 'open-label' study, meaning both the patients and the doctors will know that the medicine being given is PRAX-628. This trial is an important step in understanding if PRAX-628 could be a helpful new treatment option for people living with these types of epilepsy.

Beyond simply counting seizures, the study will also look at how PRAX-628 affects a person's overall well-being and quality of life, as well as monitoring various health markers like heart activity (ECG), blood test results, and any changes in mood, including thoughts of self-harm. All this information helps doctors get a complete picture of how the medicine works in people.

Key takeaways

Tests a new medicine (PRAX-628) for specific types of seizures.
Main goal is to see if it reduces seizure frequency and is safe.
For adults aged 18 and over, both men and women.
Regular health checks and seizure tracking will be part of the study.
Participants can leave the study at any time.
It's a Phase II trial, so the medicine is still in early testing.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part. The main requirement is that you have been diagnosed with either focal onset seizures or primary generalized tonic-clonic seizures. There will be other specific health checks to make sure the study is a good fit for you.

It's important to understand that not everyone with these seizure types will be able to join. There might be some other medical conditions or medicines you are taking that would mean you couldn't take part, to ensure the study is safe and the results are clear. The study team will review your full medical history to confirm if you are suitable.

If you think you meet these general requirements, the study team will carry out further assessments to see if you qualify. This might include reviewing your seizure history, current medications, and overall health to make sure joining the trial is safe and appropriate for you.

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 focal onset seizures?
Do you have primary generalized tonic-clonic seizures?
Are you able to attend regular clinic appointments?
Are you able to provide informed consent (understand and agree to participate)?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would first go through a 'screening' period where doctors check if you're suitable. Once approved, you would start taking the study medicine, PRAX-628. Throughout the treatment period, you would have regular visits to the clinic so doctors can monitor your health, check for side effects, and see how well the medicine is working to control your seizures. You would likely need to keep a seizure diary to track how many seizures you have.

These visits would involve various assessments, such as blood tests, checking your heart activity with an ECG, and monitoring your vital signs like blood pressure and pulse. You would also be asked questions about your general well-being and any changes you notice. The total duration of your participation would involve an initial observation period, followed by the period where you take PRAX-628, and finally, a follow-up after you stop the medication. The exact number of visits and the duration will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new medicine that isn't yet widely available, which might help reduce your seizures. However, there are also potential risks, including side effects from the medication. While PRAX-628 is being tested for safety, all medicines can have unwanted effects, which will be carefully monitored. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. The study team will discuss all potential benefits and risks with you in detail so you can make an informed decision.

Locations (2)

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

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Unverified
Germany
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Unverified
Spain

Common questions

What kind of seizures is this study looking at?

This study is for people who have 'focal onset seizures' (which start in one part of the brain) or 'primary generalized tonic-clonic' seizures (which affect the whole brain).

What is PRAX-628?

PRAX-628 is a new medicine that researchers are testing to see if it can help reduce seizures in adults.

Will I know if I'm getting the active medicine?

Yes, this is an 'open-label' study, which means both you and the doctors will know that you are receiving PRAX-628.

How long will I be in the study?

The study involves a screening period, a treatment period with PRAX-628, and a follow-up. The full duration will be explained by the study team.

What are the main things the researchers want to find out?

The main goal is to see how much PRAX-628 can reduce the number of seizures you have each month and to check its safety and any side effects.