RecruitingPhase 2

SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures

United States100 participantsStarted 2025-07-30

Plain-language summary

This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Incidence of treatment-emergent adverse events

Timeframe: Week 1-Week 52

NCT IDNCT07141329

SponsorSupernus Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Supernus Clinical Trials