Study on PRAX-628 for Epilepsy Patients with Light-Induced EEG Response

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What is this study about?

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.

1 initial visit

Upon joining the study, an initial visit is conducted. During this visit, a medical history review, physical examination, and laboratory evaluations are performed to ensure good health, except for epilepsy.

A pregnancy test is conducted for females of childbearing potential. Consent forms are signed to confirm understanding and agreement to participate in the study.

2 baseline assessment

A baseline assessment is conducted to evaluate the photoparoxysmal electroencephalogram response (PPR) to intermittent photic stimulation. This involves monitoring brain activity in response to light flashes.

The assessment helps determine the standardized photosensitivity range (SPR) and ensures eligibility for the trial.

3 medication administration

Participants receive the study medication, PRAX-628, in capsule form. The medication is taken orally.

The dosage, frequency, and duration of administration are determined by the study protocol and communicated during the trial.

4 monitoring and follow-up

Regular monitoring is conducted to assess the safety and tolerability of the medication. This includes checking vital signs, conducting laboratory tests, and performing electrocardiograms (ECGs).

Participants are observed for any adverse events or side effects. Plasma concentrations of PRAX-628 are measured to understand how the body processes the medication.

5 final assessment

A final assessment is conducted to evaluate the reduction or abolishment of the IPS-induced PPR. This helps determine the effectiveness of the medication.

The study concludes with a review of all collected data and a discussion of the participant’s experience during the trial.

Who Can Join the Study?

Men or women between 18 and 65 years of age.
Have a diagnosis and history of epilepsy and are taking between 0 to 3 anti-epileptic medications.
Show a specific type of brain response called IPS-induced PPR (a reaction to flashing lights) with a standardized photosensitivity range of at least 4 points in at least one eye condition during initial tests.
Be in good health, except for epilepsy, as determined by medical history, physical examination, and lab tests during initial tests.
Have a body mass index (BMI) between 18 and 35 kg/m² and weigh at least 50 kg. BMI is a measure of body fat based on height and weight.
If female and capable of having children, must not be pregnant or breastfeeding, have negative pregnancy tests during initial tests, and not plan to become pregnant during the trial.
If female and not capable of having children due to surgery or menopause (at least 1 year without menstrual periods), must have confirmation through a hormone test during initial tests. If capable of having children, must agree to use effective birth control methods during the trial. If male, must agree to use effective birth control methods during the trial.
Be able and willing to provide written consent and follow all study requirements.

Who Cannot Join the Study?

Participants who do not have epilepsy with IPS-induced PPR (a specific type of brain response to flashing lights) cannot join the study.
Participants who are not within the specified age range for the study cannot join. The age range is not specified here, but it is important to check if you fit the required age group.
Participants who are part of a vulnerable population, which means they might need special protection or care, cannot join the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre for Human Drug Research	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	06.05.2023

Trial locations

Investigated drugs:

Prax-628

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.

Investigated diseases:

Epilepsy

Epilepsy with IPS-induced photoparoxysmal response – This condition is characterized by abnormal brain activity triggered by intermittent photic stimulation (IPS), such as flashing lights. It is a type of epilepsy where exposure to certain visual stimuli can provoke a photoparoxysmal response (PPR) on an electroencephalogram (EEG). The PPR is an abnormal EEG pattern that can occur in response to visual stimuli, indicating increased brain excitability. Individuals with this condition may experience seizures when exposed to specific visual patterns or lights. The progression involves the persistence of this sensitivity to visual stimuli, which can vary in intensity and frequency. The condition is not classified as a rare disease.

Trial ID:

2023-504803-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on PRAX-628 for Epilepsy Patients with Light-Induced EEG Response

What is this study about?

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