Long-term study of SPN-817 in adults with focal seizures
Tests SPN-817 for long-term safety and effects in adults with focal seizures.
Plain-language title generated from the registry record
Registry title: SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Key facts
- Where
- DO NOT EDIT, PolandSee the site
- Phase
- Phase 2
Where in Poland
- Article 11 CTR PLDO NOT EDIT, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Supernus Pharmaceuticals, Inc.
- Trial code
- NCT07141329EU 2026-526361-15-00
- Record updated
- 27 October 2026
- Original description
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.Read full original descriptionShow less
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
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.