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.
Key facts
- Who runs it
- Biohaven Therapeutics Ltd.
- Where
- Helsinki, Kuopio, and Tampere, FinlandSee the 3 sitesAlso in 26 other countries, 277 sites
- Trial code
- Registry title
- Long-term Safety and Tolerability of BHV-7000
- Status
- Enrolling by invitation
- Phase
- Phase 2
- People taking part
- 660 people, planned
- Started
- 30 Jul 2024
- Expected to end
- Jan 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- BHV-7000
- Record updated
- 1 May 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 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
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
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?
Where in Finland
Also in 26 other countries, 277 sites
- HUS-YhtymaeHelsinki, FinlandTaking people
- Pohjois-Savon hyvinvointialueKuopio, FinlandTaking people
- Tampere University HospitalTampere, FinlandTaking people
About the trial
What the trial wants to find out
A study to determine if BHV- 7000 is safe and tolerable in adults with refractory focal onset epilepsy
The 2 groups in the trial
- BHV-7000 50 mgTreatment being tested
Treatment: BHV-7000
- BHV-7000 75 mgTreatment being tested
Treatment: BHV-7000
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 → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Long-term safety study of BHV-7000 for hard-to-treat focal epilepsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06443463, who can take part
- Record updated
- 1 May 2026