SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
RecruitingPhase 2
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Completed antecedent SPN-817 double-blind study 2. 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: 1. Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures 2. 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.
About the study
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
What is being tested
- SPN-817 (drug)
Sponsor: Supernus Pharmaceuticals, Inc. · Participants: 100 · Started: Jul 30, 2025
Contact the study team
- Supernus Clinical Trials · Phone: 240-403-5838
- Navid Saeidi, MS · Phone: 240-403-5328
Official record on ClinicalTrials.gov — NCT07141329
Locations in the U.S.
| Florida | Medsol Clinical Research Center, Port Charlotte |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.