Unknown Brain & Nervous System NIHR-supported project Cancer

BHV7000-201 - A Phase 2/3, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Funder NIHR (part of DHSC)
Recipient organisation NIHR Wellcome Trust UCL Clinical Research Facility
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Ongoing

In plain English

AI plain-English summary

A new drug candidate, BHV-7000, is being tested in a long-term safety study for adults whose focal seizures do not respond to existing treatments. This matters because current antiseizure drugs often fail to control seizures in people with refractory focal onset epilepsy—where seizures begin in one region of the brain—and can cause burdensome side effects. BHV-7000 works by increasing the opening of a specific channel protein on brain cells, Kv7.2/7.3, which regulates electrical activity. Its unique molecular structure is thought to make it safer and better tolerated than existing options. If the study shows BHV-7000 is safe and reduces seizures, it could offer a new treatment option for people who have run out of effective therapies. For patients, this could mean fewer seizures and fewer side effects, improving daily life and reducing the risk of injury or hospitalisation. For the health system, a well-tolerated drug could lower the long-term costs of managing uncontrolled epilepsy, including emergency care and specialist visits. The research is a late-stage clinical trial, not fundamental science, and its direct goal is to assess safety and tolerability in a real-world patient population.

View original technical description
Epilepsy is a neurological disease characterized by unexpected seizures. Refractory focal onset epilepsy is a type of epilepsy in which seizures start in one part of the brain and are not well-controlled despite patients taking antiseizure treatments. Several antiseizure drugs are currently available, but they do not always ensure good control of seizures and can cause many side effects. The investigational drug BHV-7000 is a small molecule that works by increasing the opening of a channel protein called Kv7.2/7.3. The Kv7.2/7.3 channel is present on the surface of brain cells and regulates the brain’s electrical activity. By increasing its opening, BHV-7000 is thought to prevent seizures. BHV-7000 is also believed to be safer and better tolerated compared to other antiseizure drugs due to its unique structure.The proposed study is a Phase 2 study that aims to evaluate if BHV-7000 is safe to use and if it reduces seizures in adults with refractory focal epilepsy.Approximately 660 eligible subjects will enter this study after completing the double-blind phase of either the parent studies (in the UK this is BHV7000-303). The study will consist of a 52-week treatment phase followed by a 2-week follow-up phase involving assessments including physical exams, vital signs, ECG, blood and urine samples, questionnaires and diary review.

Researchers

Matthias Koepp (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

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
BHV7000-303 - A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy
A Phase 2/3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy (RISE-3)
A Phase 2B, Multicenter, 30-week, Prospective, Cross-over, Double-blind, Randomized, Placebo-controlled Study Followed by a 52-Week Open-label Extension Study to Evaluate the Efficacy and Safety of Basimglurant Adjunctive to Ongoing Anticonvulsive Therapy in Children, Adolescents, and Young Adults with Seizures Associated with Tuberous Sclerosis Complex. (GALENE (NOE-TSC-201))
AAV-delivery of enhanced potassium channel in refractory epilepsy: CTA-enabling preclinical development programme

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