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
- Balvanera, Buenos Aires, Ciudad Autónoma de Buenos Aires, Córdoba, and San Miguel de Tucumán, ArgentinaSee the 10 sites
- Phase
- Phase 2
AI summary: who the study is looking for
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 epilepsy that is hard to control, who finished the double-blind phase of an earlier BHV-7000 study. It tests the long-term safety of BHV-7000.
- Age
- 18 to 75 years
- Sex
- Women and men can join.
- Disease stage
- Refractory focal onset epilepsy (focal epilepsy that is hard to control with treatment).
- Earlier treatment
- Must have finished the double-blind phase of the earlier study BHV7000-302 or BHV7000-303.
Main reasons for not taking part
- A health problem that would stop the person from following the study instructions or would put them at unacceptable risk, as judged by the investigator
- Poor tolerance of the study drug in the double-blind phase of the earlier study
- A medical condition that would make it hard to measure safety and effect, as judged by the investigator
Read by machine on 9 November 2026.
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 Argentina
- Hospital General de Agudos Dr. José María Ramos MejiaBalvanera, ArgentinaNo longer taking part
- Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC-Elías Galván 4102Buenos Aires, ArgentinaNo longer taking part
- Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)Buenos Aires, ArgentinaNo longer taking part
- Hospital Britanico de Buenos AiresBuenos Aires, ArgentinaNo longer taking part
- Hospital Italiano de Buenos AiresBuenos Aires, ArgentinaNo longer taking part
- Sanatorio de la Trinidad - MitreBuenos Aires, ArgentinaNo longer taking part
- Stat Research S.A.Ciudad Autónoma de Buenos Aires, ArgentinaNo longer taking part
- Conci Carpinella - Santa Rosa N° 748Córdoba, ArgentinaNo longer taking part
- Instituto Privado KremerCórdoba, ArgentinaNo longer taking part
- Investigaciones Sanatorio Del SurSan Miguel de Tucumán, ArgentinaNo longer taking part
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.