The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
390
Change from Baseline in 28-day average seizure frequency
To compare the efficacy of 75mg of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency. The primary objective will be measured by comparing the observation phase (8 weeks) to the 8-week double-blind treatment phase.
Time frame: Baseline, Week 8 to Week 16
Percentage of Participants with at at least 50% reduction in seizure frequency per month
To compare the efficacy 75mg of BHV-7000 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). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.
Time frame: Baseline, Week 8 to Week 16
Change from Baseline in 28-day average seizure frequency
To compare the efficacy of each of 50mg of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from OP (observational phase) in 28-day average seizure frequency.
Time frame: Baseline, Week 8 to Week 16
Percentage of Participants with at at least 50% reduction in seizure frequency per month
To compare the efficacy of 50mg of BHV-7000 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). This objective will be measured by comparing the proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the 8 week double-blind phase to the observation phase.
Time frame: Baseline, Week 8 to Week 16
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Number of Participants With Deaths, Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation, and moderate or severe AEs
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, and moderate and severe AEs.
Time frame: Week 8 to Week 16
Number of Participants With Clinically Significant Laboratory Abnormalities
To assess the safety and tolerability of BHV-7000. This objective will be measured by assessing the number of unique subjects with grade 3 or 4 laboratory abnormalities.
Time frame: Week 8 to Week 16