This clinical trial is focused on studying a condition known as refractory focal onset epilepsy. This type of epilepsy is characterized by seizures that begin in one area of the brain and are difficult to control with standard treatments. The study is investigating a new treatment called BHV-7000, which is a prolonged-release tablet designed to be taken orally. The purpose of the study is to evaluate the safety and tolerability of BHV-7000 in adults who have this form of epilepsy.
Participants in the study will receive the medication BHV-7000 over a period of time to see how well it is tolerated and to monitor any side effects. The study will also include a comparison with a placebo to better understand the effects of the medication. The trial is designed to be long-term, lasting up to 52 weeks, to gather comprehensive data on the safety of the treatment.
Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to collect information on any changes in their condition. The ultimate goal is to determine if BHV-7000 can be a safe and effective treatment option for individuals with refractory focal onset epilepsy, potentially offering a new avenue for managing this challenging condition.
1joining the study
Participation begins after completing the double-blind phase of a previous study, either BHV7000-302 or BHV7000-303.
Females of childbearing potential must have a negative urine pregnancy test at the baseline visit, also known as Day 0.
2medication administration
The medication used in this study is called BHV-7000.
It is administered in the form of a prolonged-release tablet.
The route of administration is oral.
3monitoring and assessments
The main objective is to evaluate the safety and tolerability of BHV-7000.
Safety is assessed by monitoring the number of unique subjects with deaths, serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, moderate and severe AEs, and grade 3 and 4 laboratory abnormalities.
4study duration
The study is estimated to end on December 30, 2026.
Recruitment for the study is expected to start on December 1, 2024.
Who Can Join the Study?
Participants must have completed the double-blind phase of a previous study, either BHV7000-302 or BHV7000-303. The double-blind phase is a part of a study where neither the participants nor the researchers know who is receiving the treatment or placebo.
Females who can have children must have a negative urine pregnancy test at the start of the study. This means they are not pregnant when they begin the study.
Who Cannot Join the Study?
Patients who have a different type of epilepsy than Refractory Focal Onset Epilepsy cannot participate. This type of epilepsy is when seizures start in one area of the brain and do not respond well to treatment.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific characteristics in participants.
Patients who are not male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.
BHV-7000 is a medication being studied for its safety and tolerability in people with refractory focal onset epilepsy. This means it is being tested to see how safe it is for patients to use and how well patients can handle any side effects. The study is focused on individuals who have epilepsy that does not respond well to other treatments.
Refractory Focal Onset Epilepsy – This is a type of epilepsy where seizures originate in a specific area of the brain and do not respond well to standard treatments. The condition is characterized by recurrent seizures that can vary in intensity and duration. These seizures may involve motor, sensory, or autonomic symptoms, depending on the brain region affected. Over time, the frequency and severity of seizures can increase, making daily activities challenging. The condition often requires ongoing management to reduce seizure frequency and improve quality of life.
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