A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy (BHV7000-201)

Research summary

This is a Phase 2, global, multicenter, long-term safety study designed to assess the safety and tolerability of BHV-7000 in participants with focal refractory epilepsy. Approximately 660 eligible subjects will enter this study after completing the DBP of either the BHV7000-302 or BHV7000- 303 studies. In the opinion of the investigator, subjects must have tolerated BHV7000/placebo, during participation in the DBP of the parent studies, BHV7000-302 or BHV7000-303 to be eligible. Eligible subjects who completed the DBP of the BHV7000-302 study will be initially assigned BHV-7000 50 mg dose at the baseline visit. Eligible subjects who completed the DBP of BHV7000-303 study will be initially assigned BHV-7000 75 mg dose at the baseline visit (75 mg dose is comprised of one ER tablet 50 mg and one ER tablet 25 mg). All subjects will have the opportunity to take BHV-7000 for 52 weeks.

Principal Investigator

Arjune Sen

Contact us

Email: dendron@ouh.nhs.uk

IRAS number

1010242