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Enrolling By Invitation
NCT07141329
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Conditions: Focal Onset Seizures
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: Supernus Pharmaceuticals, Inc.
Location: Center for Neurosciences Tucson Arizona
Summary
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
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.
Source: ClinicalTrials.gov (NCT07141329). StuddyBuddy aggregates publicly available trial information.