Biohaven Rise 2

Primary Objective: To compare the efficacy of 2 doses of BHV-7000 to placebo as an adjunctive therapy for refractory focal onset epilepsy as measured by the change from baseline in 28-day average seizure frequency. Secondary Objcetives: -To compare the efficacy of 2 doses 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). -To compare the efficacy of BHV-7000 to placebo during the first month of treatment. To compare the efficacy of BHV-7000 to placebo during the first week of treatment. -To compare the efficacy of BHV-7000 to placebo on seizure freedom (100% seizure reduction during the DBP). -To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C) at week 12. -To assess the safety and tolerability of BHV-7000. Exploratory objectives: -To describe the blood concentrations of BHV-7000 in subjects with refractory focal onset epilepsy -To assess the effect of BHV-7000 on depression in subjects that have symptoms of depression at screening. -To assess the efficacy of BHV-7000 to placebo on the clinician global impression of disease severity. -To compare the efficacy of BHV-7000 to placebo on the patient global impression of change (PGI-C) at week 4. -To assess the efficacy of BHV-7000 to placebo on quality of life (QOL). -To assess the satisfaction of patients treated with BHV-7000 to placebo. Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP. -Proportion of subjects that are seizure free during the DBP. - Proportion of subjects at week 12 with PGI-C response of minimally improved, much improved or very much improved. -Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All