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

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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 Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Associazione La Nostra Famiglia Conegliano Italy
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Futuremeds Sp. z o.o. Wroclaw Poland

Other Sites

Site Name City Country Status
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospital Del Mar Barcelona Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Gesellschaft Fuer Epilepsieforschung Bielefeld Germany
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Klinikum Osnabrück GmbH Osnabrück Germany
Hwsmwtoe Vujk dkwozrtj Barcelona Spain
Ueftcbpzbknprrwnpogsm Tsmsuigwd Ava Tuebingen Germany
Hbkpywka Cfcrmz Df Bzuofeuap Barcelona Spain
Hlvpfxgm Uivsakrhvldxu Fwqiikvpc Jkiiuif Dlpv Madrid Spain
Hsictfws Coklttc Skh Cakfcs Madrid Spain
Aukywmn Ozqadeieyuu Umcfbmcxlmsmb Fmjqphpl Iq Dd Nzbibf Naples Italy
Hrtobyfn Dq Lt Sucij Crmd I Sroc Psp Barcelona Spain
Utmwtsqlpj Dqvmr Shetk Du Rmkn Lf Sxsaydgf Rome Italy
Hyktruek Umahstkbhppuz Dx Lj Pzfjendi Madrid Spain
Hhdwzmne Uvevsqrkgjoim Vkxlfz Dm Lfj Nkpwdc Granada Spain
Fztaqiafsp Ioqkdaldlb Imewrhqq Nczjyzqgdne Bqujj Milan Italy
Nirclkvv Ztgghtued I Wlvgioluw Sjb jy Katowice Poland
Nkmqinxswuhw Zibgkb Odpylp Zudqpnmsax Wxrpollnmgybzbhyunho Pxcvwzfu Lojfqtan Syosmomq Lvxu Sklemmjjwvqn Katowice Poland
Uzfoigioirdhidxfa Cjfzai Bfzodakytr Dz Rccs Rome Italy
Ispbvacm Ntfimwjchpn Mmwbsxxqytwf Niluveyc Saagee Pozzilli Italy
Gbsayb Unsrpimxkl Flasmkibx Frankfurt Germany
Fhreovuv Axnursxknmbe Db Msfix Do Tgafcbyu Fdf Terrassa Spain
Aozzizd Swwvyvhqz Lwylay Dgfdj Piubeidnm Dy Bqlwnp Ponderano Italy
Fffxivzzpe Iucfpdnn Nyhuxfsqgey Ngqrreoxv Cpnblkcr Mfvemep Pavia Italy
Myj Cnunejzv Ryywynkv Pszggix Ba Ptimmz Warsaw Poland
Ccddoqh Mbbgucry Ntnygbws Siz z osqj Bydgoszcz Poland
Hsrltmvl Vphtog Lu Shtak Granada Spain
Hqhfxvgf Lh Mgxrputpl Swip Madrid Spain
Aleomwl Ozxxpnjrdcx Ublrcxdohrgfz Dm Cdwkhwyo Monserrato Italy
Uadtekhnwi dxfvx swygo Gfkccpgi Daciomjlmp Cabqbfthwgpxro Czavgq dt Sffsw e tbsgpjlqyd aetniaiq Chieti Italy
Iuidu Ootptmfz Pspkkvpkino Swc Mjvpews Genoa Italy
Cxlh Symrqclx Dhvyu Sgfnzxuwgy San Giovanni Rotondo Italy
Aadtvki Ocvhshljntl Ufdcvwutnaoou Paqwni Pisa Italy
Upnlekniaadc Du Suvqiwnr Dx Cacotizpkm Santiago De Compostela Spain
Hngpghwt Ugwrgcyifdqml Lvrky Aimxquh Lugo Spain
Cccqrb dx Nhbxltuagg Aktobfjg Sevilla Spain
Jfbsdgnhfcmkkjajsgpfkmtiqk Gfxchyr Giessen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

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

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