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A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
EU CTIS ID: 2023-508539-30-00
What this study is testing
Part A: To assess the safety and tolerability of BHV-7000 25 mg and 50 mg in subjects with refractory focal onset epilepsy. Part B: 'To compare the efficacy of BHV-7000 75mg to placebo as adjunctive therapy for refractory focal onset epilepsy as measured by the proportion of subjects that have at least a 50% reduction in seizures per month (28 days).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Signed Written Informed Consent 2. Subject and/or caregiver must be able to read and understand eDiary in an available language. 3. Subjects must be able to swallow the BHV-7000 IP tablet(s) whole. 4. Male and Female subjects 18 to 75 years of age at time of consent 5. Ability to keep accurate seizure diaries and miss no more than 4 entries (daily seizure diary) out of 28 days demonstrating 85% or greater compliance with eDiary during OP. 6. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. 7. Focal seizures (1) Focal aware seizures with clinically observable signs and/or symptoms (2) Focal impaired awareness seizures (3) Focal to bilateral tonic-clonic seizures 8. Drug Resistant Focal Onset Seizures (1) Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used ASM schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom. 9. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total.
You likely can't join if
- 1. Non-focal seizures defined by ILAE criteria (1) EEG shows any pattern not consistent with focal etiology of seizures (e.g., generalized spike-wave). (2) Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms. (3) Subjects with confirmed generalized onset seizures. 2. History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit. 3. Resection neurosurgery for seizures < 4 months prior to the screening visit. 4. Radiosurgery performed < 2 years prior to the screening visit. 5. Any condition 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.
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Chile
- Switzerland
- United States
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Chile; Switzerland; United States; South Africa. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.