NCT07141329Enrolling by invitationPhase 2
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 19 Aug 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Diseases
- Epilepsy
- NCT number
- NCT07141329
- EU CT number
- 2026-526361-15-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 30 Jul 2025 to the primary completion date, 31 Dec 2027
- 11 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Article 11 CTR BG Coordinator of this site? Confirm its status | DO NOT EDIT | Bulgaria | Not yet recruiting |
| Article 11 CTR HU Coordinator of this site? Confirm its status | DO NOT EDIT | Hungary | Not yet recruiting |
| Article 11 CTR PL Coordinator of this site? Confirm its status | DO NOT EDIT | Poland | Not yet recruiting |
| Asheville Neurology Specialists Coordinator of this site? Confirm its status | Asheville | United States | Unknown status |
| Ilumina Medical Research Coordinator of this site? Confirm its status | Kissimmee | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Medsol Clinical Research Center Coordinator of this site? Confirm its status | Port Charlotte | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Center for Neurosciences Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Focus Clinical Research Coordinator of this site? Confirm its status | West Hills | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.