Focal Onset Seizures
Conditions
Keywords
focal seizures, focal epilepsy, open-label extension, anti-seizure medication
Brief summary
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Detailed description
This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This study will include a double-blind Dose Titration/Bridging Period of 8-10 weeks in which SPN-817 will be titrated to the participant's maximum tolerated dose based on response. Following the Dose Titration/Bridging Period, participants will enter an Open Label Extension (OLE) Period of 42-44 weeks. When participants finish the OLE Period, they will initiate a Tapering Period (up to 4 weeks) followed by an End-of-Tapering Period video contact (VC) after the last dose of study drug. The duration of study treatment before starting the 4-week Tapering Period will be one year (52 weeks).
Interventions
DRUGSPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events | Week 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period | Baseline and Treatment Period (Week 1-52) | Percent change in 28-day frequency of quantifiable focal seizures during the 1-year Treatment Period relative to baseline |
| Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline | Baseline and Treatment Period (Week 1-52) | Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 1-year Treatment Period relative to baseline. |
| Proportion of participants experiencing seizure freedom | Baseline and Treatment Period (Week 1-52) | 100% reduction in 28-day frequency of focal seizures during the Treatment Period relative to baseline |
| Percentage of seizure-free days over the 1-year SPN-817 Treatment Period | Week 1-Week 52 | The number of seizure-free days reported for each participant divided by the total number of days with seizure data reported, multiplied by 100. |
Countries
United States
Contacts
Primary ContactSupernus Clinical Trials
Backup ContactNavid Saeidi, MS
Outcome results
None listed