Long-term safety study of BHV-7000 for hard-to-treat focal epilepsy
Tests whether BHV-7000 is safe over time in adults with hard-to-treat focal epilepsy.
Plain-language title generated from the registry record
Registry title: Long-term Safety and Tolerability of BHV-7000
Key facts
- Where
- Ancona, Bologna, Catanzaro, Chieti Scalo, Florence, Genoa, Milan, Modena, Naples, Pavia, Pozzilli, Rome, and Verona, ItalySee the 17 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06443463, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
- Azienda Unita Sanitaria Locale Di BolognaBologna, ItalyTaking people
- Azienda Ospedaliero Universitaria Renato DulbeccoCatanzaro, ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, ItalyTaking people
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale Antonio CardarelliNaples, ItalyTaking people
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
- Azienda Ospedaliera Policlinico Universitario Tor VergataRome, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Ospedale Pediatrico Bambino GesùRome, ItalyTaking people
- Azienda Ospedaliera Universitaria Integrata VeronaVerona, ItalyTaking 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
- Biohaven Therapeutics Ltd.
- Trial code
- NCT06443463EU 2023-508813-18-00
- Record updated
- 1 May 2026
- Original description
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsyRead full original descriptionShow less
A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
Inclusion: Subjects who completed the double-blind phase (DBP) of prior parent study, BHV7000-302 or BHV7000-303; (FOCBP) Females of Child Bearing Potential must have a negative urine pregnancy test at the Baseline/Day 0 visit.
Exclusion: Any condition, such as an ongoing AE with/without sequelae, or is poorly tolerating IP in the double-blind phase of the parent study, that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator; Any medical condition, based on the judgement of the Investigator, that would confound the ability to adequately assess safety and efficacy outcome measures.