Study Details
Testing the Study Drug BHV-7000 for People with Focal Epilepsy
(IRB#: IRB_00176113)
Focal Epilepsy is a partial seizure caused by a specific area of the brain and affects one side of the body. This study will test a drug called BHV-7000 for people with this condition who are taking anti-seizure medications but still have seizures. The study wants to see if the study drug will help people and is safe. People in this study will be randomly chosen to be treated with BHV-7000 or a placebo. The placebo looks like the study drug but does not have the treatment. People in the study will continue to take the current dose of the anti-seizure medication while taking BHV-7000 or the placebo. Participants in the study will track seizures in an electronic diary and record when the study drug is taken, and any other medications. Being in the study requires attending in-person visits at the study clinic. Participation lasts about 20 to 22 weeks. Medical tests will be done to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 35 to 75 years and older
- Diagnosed with focal onset epilepsy at least 1 year before participation
- Be on a stable dose of at least 1 and up to 3 antiseizure medication(s) for at least 1 month and remain stable on the study drug treatment until the end of the study
- Able to complete electronic diary
- Able to attend in person at the study clinic
Exclusion Criteria
- A condition that prevents full participation
- Participation in another clinical trial
- History of alcohol or drug use disorder within the previous 2 years
- Diagnosis of severe mental health disorder that affects participation
- Suicide behavior within the previous 2 years
Will I be paid for my time?
Yes
IRB#: IRB_00176113
PI: Amir Arain
Department: NEUROLOGY
Approval Date: 2024-06-12 06:00:00
Study Categories: Brain Health Studies
Specialties: Neurology