Phase 2 Study of SPN-817 for Focal Onset Seizures
This study is testing a drug called SPN-817 for adults with focal onset seizures (seizures that start in one area of the brain). You might be able to join if you are between 18 and 70 years old, have been diagnosed with treatment-resistant focal epilepsy, and have tried at least two other seizure medications without success. The main goal is to see how much SPN-817 can reduce the number of focal onset seizures you have over 28 days, compared to a placebo (an inactive substance). The study is currently unclear about its recruitment status and plans to enroll 216 participants.
- Study design
- This is a Phase 2, double-blind (you and your doctor won't know if you're getting the study drug or placebo), randomized study. About 216 adults will participate, with some receiving SPN-817 and others receiving a placebo.
- What's involved
- You would take SPN-817 or placebo twice a day, starting with a lower dose and gradually increasing it over 8-10 weeks. This would be followed by a 14-week maintenance period. You would also need to keep accurate electronic diaries of your seizures.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants who complete the 14-week Maintenance Period may have the opportunity to enroll in a separate open-label study for continued treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled 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
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What this trial measures
- Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance PeriodBaseline and Maintenance Period (Maintenance Week 1-14)
Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline