An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures (NCT07141329)

This proposed study 817P210, is a Phase 2 Extension study aiming to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures, who have previously completed study 817P203 (a double blind study approved by this same HREC). The study is planned to involve a minimum of 100 of the patients that participated in the parent study. Upon enrollment, the participants will undergo a blinded Dose Titration Period of 8-10 weeks, in which Study Drug will be titrated to the participant's maximum tolerated dose (MTD) based on response. The SPN-817 MTD dose will be required to between 1.0 to 4.0 mg BID. After this, the participants will enter the proper open label extension period (at their MTD dose) . The combined duration of treatment with SPN-817 will be approximately 56 weeks.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Inclusion Criteria •Completed antecedent SPN-817 double-blind study •Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs Exclusion Criteria •Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures •Has any suicidal behavior or suicidal ideation related to active suicidal ideation with some intent to act without specific plan or active suicidal ideation with specific plan and intent based on the C-SSRS assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt.