Status:
RECRUITING
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Lead Sponsor:
Supernus Pharmaceuticals, Inc.
Conditions:
Focal Onset Seizures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Detailed Description
This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This stu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07141329
Start Date
July 30 2025
End Date
December 31 2027
Last Update
October 10 2025
Active Locations (1)
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1
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952