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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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (44)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Gesellschaft Fuer EpilepsieforschungBielefeldGermanyRecruiting
Universitaetsklinikum Bonn AöRBonnGermanyRecruiting
Universitaetsklinikum Frankfurt AöRFrankfurt Am MainGermanyRecruiting
Universitaetsklinikum Giessen und Marburg GmbHMarburgGermanyRecruiting
Klinikum Osnabrueck GmbHOsnabrueckGermanyRecruiting
Universitaetsklinikum Tuebingen AöRTuebingenGermanyRecruiting
Hospital de la Santa Creu i Sant PauBarcelonaSpainRecruiting
Hospital Universitari Vall d'HebronBarcelonaSpainRecruiting
Hospital del MarBarcelonaSpainRecruiting
Hospital Clinic de BarcelonaBarcelonaSpainRecruiting
Hospital Universitario Virgen de las NievesGranadaSpainRecruiting
Hospital Vithas La SaludGranadaSpainRecruiting
Hospital Universitario Lucus AugustiLugoSpainRecruiting
Hospital Blua Sanitas ValdebebasMadridSpainRecruiting
Hospital La Milagrosa S.A.MadridSpainRecruiting
Hospital Universitario de la PrincesaMadridSpainRecruiting
Hospital Clínico San CarlosMadridSpainRecruiting
Hospital Universitario Fundación Jiménez DíazMadridSpainRecruiting
Hospital Universitario Regional de MálagaMálagaSpainRecruiting
Complexo Hospitalario Universitario De SantiagoSantiago de CompostelaSpainRecruiting
Centro De Neurologia Avanzada S.L.P.SevillaSpainRecruiting
Fundacio Assistencial De Mutua De Terrassa FpcTerrassaSpainRecruiting
Hospital Universitario Y Politecnico La FeValenciaSpainRecruiting
Hospital Clínico Universitario de ValladolidValladolidSpainRecruiting
Azienda Unita Sanitaria Locale Di BolognaBolognaItalyRecruiting
Universita' Degli Studi G. D'Annunzio Di ChietiChieti ScaloItalyRecruiting
IRCCS Eugenio Medea - Sezione scientifica dell'Associazione "La Nostra Famiglia"ConeglianoItalyRecruiting
IRCCS Azienda Ospedaliera MetropolitanaGenoaItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo BestaMilanItalyRecruiting
Azienda Ospedaliero-Universitaria Di CagliariMonserratoItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaplesItalyRecruiting
Fondazione Istituto Neurologico Nazionale Casimiro MondinoPaviaItalyRecruiting
Azienda Ospedaliero Universitaria PisanaPisaItalyRecruiting
Azienda Sanitaria Locale Della Provincia Di BiellaPonderanoItalyRecruiting
Istituto Neurologico Mediterraneo Neuromed S.p.A.PozzilliItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto IRomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRomeItalyRecruiting
Casa Sollievo della SofferenzaSan Giovanni RotondoItalyRecruiting
Centrum Medyczne Neuromed Sp. z.o.o.BydgoszczPolandRecruiting
Novo-Med Zielinski I Wspolnicy Sp. j.KatowicePolandRecruiting
Niepubliczny Zaklad Opieki Zdrowotnej Wielospecjalistyczna Poradnia Lekarska Synapsis Lech SzczechowskiKatowicePolandRecruiting
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.LublinPolandRecruiting
MTZ Clinical Research powered by PratiaWarsawPolandRecruiting
Futuremeds Sp. z o.o.WarsawPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.