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

{ "SPN-817 Open-Label Extension Study for Focal Onset Seizures", "This study is looking at the long-term safety and how well SPN-817 works for adults with focal onset seizures (seizures that start in one part of the brain). You can join if you are 18 or older, have completed a previous SPN-817 study, and are taking a stable dose of 1 to 4 other anti-seizure medications. The main goal is to track any side effects you might experience over 52 weeks. The study aims to enroll 100 participants, but its current recruitment status is unclear.", "design": "This is a Phase 2b, open-label extension study, meaning both you and your doctors will know you are receiving SPN-817. It will include about 100 adult participants.", "commitments": "You will start with an 8-10 week period where the SPN-817 dose is adjusted, followed by 42-44 weeks of treatment. After that, there will be a tapering period of up to 4 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Your safety will be monitored for 52 weeks, and there will be a video contact after your last dose of the study drug.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07141329

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Supernus Pharmaceuticals, Inc.
~100 participants
Updated 2025-10-10 on ClinicalTrials.gov
What's tested:SPN-817

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over Week 1-Week 52
Focal Onset Seizures
1 sites across 1 states
Florida1
  • Maciej Gasior, MD, PhD · STUDY_DIRECTOR · Supernus Pharmaceuticals, Inc.

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  • Incidence of treatment-emergent adverse eventsWeek 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