RecruitingPhase 2NCT07141329
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Sponsor
Supernus Pharmaceuticals, Inc.
Enrollment
100 participants
Start Date
Jul 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Eligibility
Min Age: 18 Years
Inclusion Criteria2
- 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 Criteria2
- 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 Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt.
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Interventions
DRUGSPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07141329