Study on PRAX-628 for Adults with Focal Onset or Generalized Tonic-Clonic Seizures

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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 adults who experience certain types of seizures. The seizures being studied are known as focal onset seizures and primary generalized tonic-clonic seizures. These are types of epilepsy where the person may experience sudden bursts of electrical activity in the brain, leading to convulsions or other symptoms.

The purpose of the study is to evaluate how effective PRAX-628 is in reducing the frequency of these seizures. Participants in the study will take PRAX-628 in the form of a capsule, which is taken orally. The study will last for a period of up to eight weeks, during which participants will continue their usual anti-seizure medications while adding PRAX-628 to their treatment plan. The study will monitor changes in seizure frequency and any side effects experienced by participants.

Throughout the study, participants will be asked to keep a diary of their seizures and any changes they notice. The study aims to see if PRAX-628 can help reduce the number of seizures and improve the overall quality of life for those affected by these types of epilepsy. The results will help determine the safety and effectiveness of PRAX-628 as a potential new treatment option for people with these seizure disorders.

1 screening/observation period

During this period, the participant’s seizure frequency is monitored. The participant must record at least 2 countable seizures for focal onset or 1 countable primary generalized tonic-clonic seizure.

The participant’s seizure diary must be completed for at least 80% of the days over a 4-week period.

2 treatment period

The participant begins taking PRAX-628 in capsule form, administered orally.

The dosage and frequency of PRAX-628 are determined by the study protocol and are adjusted based on the participant’s response and any side effects experienced.

The primary goal is to evaluate the change in seizure frequency from the screening period to the treatment period.

3 monitoring and assessment

The participant’s health is monitored through regular assessments, including vital signs, clinical laboratory tests, and ECG parameters.

The impact of PRAX-628 on the participant’s condition is evaluated using specific scales such as PGI-S and CGI-S.

The incidence and severity of any side effects are recorded, and adjustments to the treatment may be made if necessary.

4 end of treatment evaluation

At the end of the treatment period, the participant’s seizure frequency is compared to the baseline established during the screening period.

The study assesses the proportion of participants experiencing a significant reduction in seizure frequency or complete seizure freedom.

Who Can Join the Study?

The participant must be willing to sign a document that shows they understand the purpose of the clinical trial and agree to follow all the procedures, including keeping a record of seizures and using birth control if needed.
The participant must be between 18 and 75 years old at the time of joining the study.
The participant must have been diagnosed with one of the following types of seizures: focal onset seizures (which start in one area of the brain), focal onset to bilateral generalized seizures (which start in one area and spread to both sides of the brain), or primary generalized tonic-clonic seizures (which affect the whole brain from the start).
The participant must have had a CT or MRI scan in the past that shows their epilepsy is not caused by a condition that gets worse over time.
The participant must be taking a stable dose of 1 to 3 anti-seizure medications (ASMs) for at least four weeks before starting the study. ASMs are drugs used to control seizures.
The participant must have had at least 2 countable focal onset seizures per month or 1 countable generalized tonic-clonic seizure per month in the 3 months before starting the study. Countable seizures are those that can be clearly identified and recorded.
During the study’s initial period, the participant must record at least 2 countable seizures if they have focal onset seizures, or 1 countable primary generalized tonic-clonic seizure if they have that type.
The participant must complete their seizure diary on at least 80% of the days during the 4-week initial period of the study.

Who Cannot Join the Study?

Patients who are not currently taking medications for seizures, known as ASMs (Anti-Seizure Medications), cannot participate.
Individuals who do not have focal onset seizures or primary generalized tonic-clonic seizures are excluded. Focal onset seizures start in one area of the brain, while primary generalized tonic-clonic seizures affect the whole brain and cause convulsions.
People who are not within the specified age range for the study cannot join. The study is for adults, which typically means individuals aged 18 and older.
Both males and females can participate, but those who do not identify as either are not eligible.
Individuals considered part of a vulnerable population, such as those unable to give informed consent, are not allowed to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Hospital Del Mar	Barcelona	Spain
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
Hospital La Milagrosa S.A.	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Klinikum Osnabrück GmbH	Osnabrück	Germany
Hkodomxw Uwwevdexthivg Dd Ls Pfmkthkz	Madrid	Spain
Gtedpq Umlpkeluxr Fjazbixwi	Frankfurt	Germany
Hiuurquo Dg Le Sxwpl Ckdw I Sjuf Pzw	Barcelona	Spain
Hgvapyif Vnmx dkfhyxgd	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	15.02.2025
Spain	Not recruiting	15.02.2025

Trial locations

Investigated drugs:

Prax-628

PRAX-628 is a medication being studied for its ability to reduce the frequency of seizures in adults. It is specifically being tested in patients who experience focal onset seizures or primary generalized tonic-clonic seizures. The trial aims to assess how effective and safe this medication is for individuals who are already taking other anti-seizure medications.

Focal Onset Seizures – These seizures begin in one specific area of the brain and can affect various functions depending on the region involved. They may cause motor symptoms like jerking movements or non-motor symptoms such as changes in sensation or emotions. Sometimes, they can evolve into generalized seizures, affecting the entire brain. Individuals may remain aware during the seizure or experience altered awareness. The duration and frequency of these seizures can vary widely among individuals.

Primary Generalized Tonic-Clonic Seizures – These seizures involve the entire brain from the onset and are characterized by a combination of muscle stiffness (tonic phase) and rhythmic muscle contractions (clonic phase). They often begin with a sudden loss of consciousness, followed by the tonic and clonic phases. The person may fall to the ground and experience convulsions, which can last for a few minutes. After the seizure, confusion and fatigue are common as the brain recovers. These seizures can occur without warning and may be triggered by various factors.

Trial ID:

2024-517061-16-01

Protocol code:

PRAX-628-212

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on PRAX-628 for Adults with Focal Onset or Generalized Tonic-Clonic Seizures

What is this study about?

Who Can Join the Study?

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