Taking people in ItalyPhase 3
Long-term safety study of vormatrigine in adults with epilepsy
Checks the safety of vormatrigine in adults with focal or generalized tonic-clonic seizures.
Key facts
- Who runs it
- Praxis Precision Medicines Inc.
- Where
- Bologna, Chieti Scalo, Conegliano, Genoa, Milan, Monserrato, Naples, Pavia, Pisa, Ponderano, Pozzilli, Rome, and San Giovanni Rotondo, ItalySee the 14 sitesAlso in 3 other countries, 30 sites
- Trial code
- Registry title
- Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 56 people, planned
- Started
- 16 Oct 2025
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional
- Record updated
- 29 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with focal or primary generalized tonic-clonic seizures who already took part in an earlier vormatrigine trial or received vormatrigine outside a trial.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Focal onset seizures or primary generalized tonic-clonic seizures.
- Earlier treatment
- Must have finished an earlier vormatrigine trial (such as PRAX-628-212 or PRAX-628-321), or have received vormatrigine outside a trial, for example in an expanded access program.
Main reasons for not taking part
- Stopped or left the treatment period of an earlier trial, unless the sponsor accepts it
- Plans to join another interventional study
- Takes a prohibited medication listed in Table 7
- Is pregnant, breastfeeding or planning to become pregnant
- Did not keep an adequate seizure diary or did not take vormatrigine as planned
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
Also in 3 other countries, 30 sites
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- IRCCS Eugenio Medea - Sezione scientifica dell'Associazione "La Nostra Famiglia"Conegliano, ItalyTaking people
- IRCCS Azienda Ospedaliera MetropolitanaGenoa, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di CagliariMonserrato, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Azienda Sanitaria Locale Della Provincia Di BiellaPonderano, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
About the trial
What the trial wants to find out
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
- Plain-language title
- Long-term safety study of vormatrigine in adults with epilepsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 29 October 2026