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.
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Maciej Gasior, MD, PhD · STUDY_DIRECTOR · Supernus Pharmaceuticals, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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