Study of PRAX-628 to evaluate safety and effectiveness in adults with epilepsy who have focal seizures or generalized tonic-clonic seizures

3 1 1

What is this study about?

This clinical trial studies the use of vormatrigine (also known as PRAX-628) in adults who have epilepsy with either focal onset seizures or primary generalized tonic-clonic seizures. These types of seizures are different forms of epilepsy where electrical disturbances in the brain cause sudden, uncontrolled movements or changes in behavior.

The study aims to determine how safe and well-tolerated vormatrigine is when given to patients who have previously received this medication in other studies or through special access programs. The medication comes in the form of capsules that are taken by mouth. The treatment period may last up to 24 months.

During the study, doctors will monitor patients’ health through various tests and check how well the medication is working to control seizures. They will pay special attention to any side effects that might occur during treatment and measure the amount of medication in patients’ blood. The study will also track changes in the severity of the condition as observed by both doctors and patients.

1 Initial participation

You will be provided with vormatrigine in the form of oral capsules for treatment of focal onset seizures or primary generalized tonic-clonic seizures

The study duration is from August 2025 to August 2027

2 Medical monitoring

Your health will be monitored through several medical tests:

Regular checks of vital signs

Laboratory tests of blood samples

Heart monitoring through electrocardiogram (ECG)

Assessment of mental health using a specific rating scale

3 Seizure tracking

You will need to maintain a seizure diary to record the frequency of seizures

The diary should be completed regularly throughout the study period

4 Regular assessments

Your impression of the severity of your condition will be evaluated using a specific scale

Medical professionals will assess the severity of your condition

Blood samples will be taken to measure the levels of vormatrigine in your system

5 Safety monitoring

Any side effects that occur during the study will be recorded and monitored

If side effects become severe, the study medication may need to be discontinued

Who Can Join the Study?

You must be willing to sign an informed consent document confirming that you understand the purpose and requirements of the clinical trial
You must have previously participated in specific clinical trials of vormatrigine (such as PRAX-628-212, PRAX-628-321) or received this medication through other approved programs
You must have shown good compliance with keeping a seizure diary (a record of your seizure activity) and taking the study medication as directed in previous trials
You must be an adult (18 years or older)
You can be either male or female
You must have a diagnosis of either focal onset seizures (seizures that start in one area of the brain) or primary generalized tonic-clonic seizures (seizures that affect the entire brain from the start)
You must be able to follow all study procedures and complete all required assessments
You must be willing to use appropriate contraception during the study period

Who Cannot Join the Study?

Age below 18 or above 65 years
Pregnant or breastfeeding women
History of allergic reactions to similar medications
Current participation in other clinical trials
Having seizures different from focal onset (seizures that start in one part of the brain) or primary generalized tonic-clonic seizures (seizures affecting the whole brain from the start)
Severe kidney or liver problems
Uncontrolled high blood pressure
History of drug or alcohol abuse within the past 2 years
Major psychiatric disorders
Use of medications that could interact with the study drug
Having other serious medical conditions that could interfere with the study
Unable to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Associazione La Nostra Famiglia	Conegliano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Novo-Med Zielinski I Wspolnicy Sp. j.	Katowice	Poland
Fondazione Istituto Neurologico Nazionale Casimiro Mondino	Pavia	Italy
Hospital Del Mar	Barcelona	Spain
Mtz Clinical Research Powered By Pratia	Warsaw	Poland
Gesellschaft Fuer Epilepsieforschung	Bielefeld	Germany
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Vithas La Salud	Granada	Spain
Hospital La Milagrosa S.A.	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
Istituto Neurologico Mediterraneo Neuromed S.p.A.	Pozzilli	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Azienda Sanitaria Locale Della Provincia Di Biella	Ponderano	Italy
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hufuyhwo Ugrlozehqfdbj Df Ln Pypwnprg	Madrid	Spain
Nhynftwcznwn Zmqmgu Ozqasi Zgqlrkhsxc Wkkiceuushbiuoohfeus Pnzviwdo Lqmqixne Sakttobx Ldwa Sqosxidklszp	Katowice	Poland
Glpsdj Ubhljkfvwh Fmuudwlnh	Frankfurt	Germany
Hpfpwnuq Dv Lo Stjro Cldv I Stlu Pat	Barcelona	Spain
Uwhexrmaxg Dsips Sanqh Dh Rvji Lh Suehuowf	Rome	Italy
Hacwejgk Vipr ddcaeryo	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	25.08.2025
Italy	Recruiting	25.08.2025
Poland	Recruiting	25.08.2025
Spain	Recruiting	25.08.2025

Trial locations

Investigated drugs:

Vormatrigine is an investigational medication being studied for the treatment of epilepsy. It is designed to help control both focal seizures (which affect one part of the brain) and primary generalized tonic-clonic seizures (which affect the entire brain). This medication aims to reduce the frequency and severity of seizures in adult patients.

Focal Onset Seizures – A type of epileptic seizure that begins in one area of the brain. These seizures can cause various symptoms depending on which brain area is affected, including twitching, unusual sensations, or changes in awareness. The person may remain conscious but experience altered awareness, or consciousness may be impaired. These seizures can sometimes spread to involve both sides of the brain.

Primary Generalized Tonic-Clonic Seizures – A type of seizure that affects both sides of the brain from the start. The seizure begins with stiffening of the muscles (tonic phase), followed by rhythmic jerking movements (clonic phase). During these seizures, a person loses consciousness, and their muscles contract and relax repeatedly. These seizures typically last for a few minutes and affect the entire body.

Trial ID:

2025-521640-38-00

Protocol code:

PRAX-628-323

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of PRAX-628 to evaluate safety and effectiveness in adults with epilepsy who have focal seizures or generalized tonic-clonic seizures

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?