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Clinical Trials in the USA / NCT07141329
Enrolling by invitation Phase 2

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

NCT07141329 · tracked via the Priya Life Science USA tracker
Sponsor
Supernus Pharmaceuticals, Inc
Phase
Phase 2
Started
2025-07-30
Last updated
2026-10-27

Condition(s) studied

Focal Onset Seizures

Investigational drug(s) / intervention(s)

SPN-817 →

SPN-817: SPN-817 starting at 0.25 mg bid up to 4.00 mg bid

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events — Week 1-Week 52
    The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period

Trial sites (8)

FacilityCityRegionStatus
Center for Neurosciences Tucson Arizona
Focus Clinical Research West Hills California
Ilumina Medical Research Kissimmee Florida
Medsol Clinical Research Center Port Charlotte Florida
University of Rochester Medical Center Rochester New York
Asheville Neurology Specialists Asheville North Carolina
Thomas Jefferson University Philadelphia Pennsylvania
The Alfred Hospital Melbourne Victoria

More Supernus Pharmaceuticals, Inc. trials in the USA

RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures Recruiting
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD Recruiting
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder Recruiting
Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule) Active, not recruiting
Real-World Patient Experiences Using Continuous Subcutaneous Apomorphine Infusion (ONAPGOTM) in the United States: Recruiting

Other trials for the same condition

RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures Recruiting
A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07141329 on ClinicalTrials.gov ↗ ← All trials in the USA