SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Recruiting · NCT07141329 · Interventional (participants receive a specific treatment) · Lead sponsor: Supernus Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 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.
Where it is running
1 location listed across 1 US state.
- Medsol Clinical Research Center - Port Charlotte, Florida, United States