2025-521640-38-00RecruitingPhase 3
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Oct 2026
Brief summary (registry, in English)
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 16 Oct 2025
- Lead sponsor
- Praxis Precision Medicines Inc.
- Diseases
- Epilepsy
- EU CT number
- 2025-521640-38-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 56
- 44 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant who plans to enter another interventional investigational study or is on any prohibited medication listed in Table 7.
Other
- Participant who withdrew or discontinued treatment from the treatment period of an eligible clinical trial unless deemed acceptable by the sponsor.
- Participant who is pregnant, lactating or planning to become pregnant.
- Participant who is ineligible for the extension clinical trial in the view of the investigator.
Who the study is looking for
- Participant and caregiver (if applicable), is willing to sign an informed consent document in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, indicating that they understand the purpose of the clinical trial; understands and can perform, complete, and comply with all the procedures and assessments that are required during the clinical trial, including the seizure diary and contraception, and is willing to participate in the clinical trial.
- Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trial, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded access program).
- Participant who had adequate seizure diary and vormatrigine adherence and had been otherwise adherent to the study procedures in the opinion of the investigator unless deemed unacceptable by sponsor.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gesellschaft Fuer Epilepsieforschung | Bielefeld | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Universitaetsklinikum Frankfurt AöR | Frankfurt Am Main | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH | Marburg | Germany | Recruiting |
| Klinikum Osnabrueck GmbH | Osnabrueck | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Recruiting |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital del Mar | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitario Virgen de las Nieves | Granada | Spain | Recruiting |
| Hospital Vithas La Salud | Granada | Spain | Recruiting |
| Hospital Universitario Lucus Augusti | Lugo | Spain | Recruiting |
| Hospital Blua Sanitas Valdebebas | Madrid | Spain | Recruiting |
| Hospital La Milagrosa S.A. | Madrid | Spain | Recruiting |
| Hospital Universitario de la Princesa | Madrid | Spain | Recruiting |
| Hospital Clínico San Carlos | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago | Santiago de Compostela | Spain | Recruiting |
| Centro De Neurologia Avanzada S.L.P. | Sevilla | Spain | Recruiting |
| Fundacio Assistencial De Mutua De Terrassa Fpc | Terrassa | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid | Valladolid | Spain | Recruiting |
| Azienda Unita Sanitaria Locale Di Bologna | Bologna | Italy | Recruiting |
| Universita' Degli Studi G. D'Annunzio Di Chieti | Chieti Scalo | Italy | Recruiting |
| IRCCS Eugenio Medea - Sezione scientifica dell'Associazione "La Nostra Famiglia" | Conegliano | Italy | Recruiting |
| IRCCS Azienda Ospedaliera Metropolitana | Genoa | Italy | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Cagliari | Monserrato | Italy | Recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli | Naples | Italy | Recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Recruiting |
| Azienda Sanitaria Locale Della Provincia Di Biella | Ponderano | Italy | Recruiting |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. | Pozzilli | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I | Rome | Italy | Recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon | Rome | Italy | Recruiting |
| Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy | Recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. | Bydgoszcz | Poland | Recruiting |
| Novo-Med Zielinski I Wspolnicy Sp. j. | Katowice | Poland | Recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski | Katowice | Poland | Recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. | Lublin | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia | Warsaw | Poland | Recruiting |
| Futuremeds Sp. z o.o. | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.