Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SPN-817

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

Locations (1)

Medsol Clinical Research Center
Port Charlotte, Florida, United States