SPN-817 open-label extension for adults with focal-onset seizures
An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
This open-label extension will try longer-term SPN-817 treatment in adults with focal-onset seizures who completed an earlier SPN-817 trial to see if it is safe and helps control seizures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Supernus Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 1 site (Port Charlotte, Florida) |
| Trial ID | NCT07141329 on ClinicalTrials.gov |
What this trial studies
This Phase 2b, multicenter open-label extension enrolls adults who completed a preceding double-blind SPN-817 study and follows them for about one year of treatment. Participants enter an 8–10 week dose titration/bridging period to reach their maximum tolerated dose, then continue in a 42–44 week open-label treatment phase before a short taper. The study collects safety, tolerability, and efficacy data during treatment and at an end-of-taper contact. Eligible participants must have been on a stable regimen of one to four antiseizure medications during the antecedent study.
Who should consider this trial
Good fit: Adults with focal-onset seizures who completed the prior double-blind SPN-817 study and are on a stable regimen of one to four antiseizure medications are ideal candidates.
Not a fit: People who have nonepileptic events that might be mistaken for seizures, those with recent severe suicidal ideation or certain suicide history, or those who did not complete the antecedent SPN-817 trial are unlikely to be eligible or benefit from this extension.
Why it matters
Potential benefit: If successful, SPN-817 could provide a tolerable longer-term treatment option that reduces seizure frequency for some adults with focal-onset seizures.
How similar studies have performed: A prior double-blind SPN-817 trial was completed, and open-label extensions like this are commonly used to collect longer-term safety and tolerability data for antiseizure medications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Completed antecedent SPN-817 double-blind study 2. Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs Exclusion Criteria: 1. Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures 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.
Where this trial is running
Port Charlotte, Florida
- Medsol Clinical Research Center — Port Charlotte, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Supernus Clinical Trials
- Email: clinicaltrials@supernus.com
- Phone: 240-403-5838
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.