Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT07125261
Brief Summary:
This is an open label study to assess the biological effect of BHV-7000 on abnormal activity recorded by the RNS System in patients with focal epilepsy implanted with the RNS System. BHV-7000 is a potassium channel activator being evaluated for use in epilepsy. Participants are offered the drug for 4 weeks. Activity during that treatment period is compared to a 90-day retrospective baseline period in which other medications and device settings were stable, and also to a 4-week withdrawal period after treatment is discontinued. The study is open to patients with RNS regardless of whether they report clinical seizures, as long as the device recordings continue to show epileptiform activity.
Detailed Description:
This is an open-label proof-of-principle study to assess the biological effect BHV-7000 on epileptiform activity detected by the RNS System. The study uses a single case experimental design in a small number of participants. Following a 90-day retrospective baseline period, there is a 4-week treatment period followed by a 4-week withdrawal period. Objective electrophysiologic biomarkers will be obtained from patients' RNS and analyzed in each participant to assess patient-level efficacy.
The primary objective of this study is to determine whether BHV-7000, a potassium channel activator, reduces the frequency of electrographic biomarkers of epileptic activity detected in patients with epilepsy who were implanted with the RNS System.
Secondary objectives are assess whether BHV-7000 withdrawal in participants leads to subsequent worsening of electrographic biomarkers of seizures compared to the treatment period, and to assess the safety and tolerability of BHV-7000 in participants with epilepsy who have been implanted with RNS.
Study:
NCT07125261
Study Brief:
Protocol Section:
NCT07125261