An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
Medsol Clinical Research Center
RECRUITING
Port Charlotte
Contact Information
Primary
Supernus Clinical Trials
clinicaltrials@supernus.com
240-403-5838
Backup
Navid Saeidi, MS
nsaeidi@supernus.com
240-403-5328
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
Experimental: SPN-817
SPN-817, bid
Related Therapeutic Areas
Sponsors
Leads: Supernus Pharmaceuticals, Inc.