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

Conditions

Refractory Focal Onset Epilepsy

Brief summary

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.

Detailed description

- Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP., - Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Proportion of subjects that are seizure free during the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of 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.

Related papers

No related papers found yet.

Interventions

DRUGBHV-7000

DRUGPlacebo for BHV-7000

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
- Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP., - Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Proportion of subjects that are seizure free during the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of 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.	—

Measure

Time frame

- Change in log-transformed 28-day adjusted seizure frequency from OP over the 12-week DBP. -Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP., - Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP. -Proportion of subjects that are seizure free during the DBP. -Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of 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.

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Countries

Austria, Belgium, Croatia, Czechia, France, Hungary, Netherlands, Poland, Slovenia

Outcome results

None listed