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

Description

This is a Phase 3 open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

Conditions

Focal Onset Seizures
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Related Conditions:

Focal Onset Seizures

Study Overview

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Study Details

Study overview

This is a Phase 3 open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures

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

Condition
Focal Onset Seizures
Intervention / Treatment

-

Contacts and Locations

Port Charlotte

Medsol Clinical Research Center, Port Charlotte, Florida, United States, 33952

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Supernus Pharmaceuticals, Inc.,

Maciej Gasior, MD, PhD, STUDY_DIRECTOR, Supernus Pharmaceuticals, Inc.

Study Record Dates

2027-12-31