Rise2
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 (RISE2)
Purpose
This is a global, multicenter, randomized, double-blind, placebo-controlled 3-arm study designed to assess the efficacy and safety of BHV-7000 in subjects with refractory focal onset epilepsy who are stable with at least 1 and up to 3 anti-seizure medications (ASMs).
Who can participate
- Adults 18 to 75 years of age
- Diagnosis of Focal Onset Epilepsy at least 1 year prior
- Drug Resistant Focal Onset Seizures
- History of an average of 4 or more observable focal seizures per month (28 days) during the 3 months prior to the screening visit
- Current treatment with at least 1 and up to 3 ASMs as part of no more than 4 stable epilepsy treatments. Implanted neurostimulation devices, resection surgery (if completed 1 year prior to the screening visit) and epilepsy dietary therapy are considered epilepsy treatments in this trial
- Patients who use vigabatrin as a concomitant ASM must be taking for at least 2 years and have appropriate documentation of normal visual fields
- If implanted vagal nerve stimulator, deep brain stimulation, responsive neurostimulator system, the stimulator, stimulation, or neurostimulator system or other neurostimulation device for epilepsy:
- Implanted or activated > 1 year prior to screening visit
- Stimulation parameters have been stable for > 3 months prior to screening visit
- Battery life of unit anticipated to extend for duration of trial
Visits
Patients can expect an 8 week observation period and then 12 weeks of visits (day 1, and weeks 2, 4, 8, and 12).
