Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
Key facts
- Where
- Barcelona, Granada, Lugo, Madrid, Málaga, Santiago de Compostela, Sevilla, Terrassa, Valencia és Valladolid, SpanyolországSee the 18 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpanyolországTaking people
- Hospital del MarBarcelona, SpanyolországTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországTaking people
- Hospital Universitario Virgen de las NievesGranada, SpanyolországTaking people
- Hospital Vithas La SaludGranada, SpanyolországTaking people
- Hospital Universitario Lucus AugustiLugo, SpanyolországTaking people
- Hospital Blua Sanitas ValdebebasMadrid, SpanyolországTaking people
- Hospital Clínico San CarlosMadrid, SpanyolországTaking people
- Hospital La Milagrosa S.A.Madrid, SpanyolországTaking people
- Hospital Universitario de la PrincesaMadrid, SpanyolországTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországTaking people
- Hospital Universitario Regional de MálagaMálaga, SpanyolországTaking people
- Complexo Hospitalario Universitario De SantiagoSantiago de Compostela, SpanyolországTaking people
- Centro De Neurologia Avanzada S.L.P.Sevilla, SpanyolországTaking people
- Fundacio Assistencial De Mutua De Terrassa FpcTerrassa, SpanyolországTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországTaking people
- Hospital Clínico Universitario de ValladolidValladolid, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Praxis Precision Medicines Inc.
- Trial code
- EU 2025-521640-38-00
- Record updated
- 2026. október 29.
- Original description
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.Read full original descriptionShow less
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
Inclusion: 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.
Exclusion: Participant who plans to enter another interventional investigational study or is on any prohibited medication listed in Table 7; 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.