RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-07-30
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07141329

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Completed antecedent SPN-817 double-blind study
  2. 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. 1. Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures
  2. 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.

Contacts and Locations

Study Contact

Supernus Clinical Trials
CONTACT
240-403-5838
clinicaltrials@supernus.com
Navid Saeidi, MS
CONTACT
240-403-5328
nsaeidi@supernus.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Supernus Pharmaceuticals, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • focal seizures
  • focal epilepsy
  • open-label extension
  • anti-seizure medication

Additional Relevant MeSH Terms

  • Focal Onset Seizures