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 8-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 8 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 BHV-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 8-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 8 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 8-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 8 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.

—

Countries

Denmark, Finland, Germany, Greece, Hungary, Italy, Portugal, Romania, Slovakia, Spain

Outcome results

None listed