Actively Recruiting
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Led by Supernus Pharmaceuticals, Inc. · Updated on 2025-10-10
100
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
CONDITIONS
Official Title
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 or specific plan based on the Columbia-Suicide Severity Rating Scale assessments in the antecedent study and at Visit 1 or has more than one lifetime suicide attempt
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Actively Recruiting
Research Team
S
Supernus Clinical Trials
CONTACT
N
Navid Saeidi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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