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This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPN-817 | Experimental | SPN-817, bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN-817 | Drug | SPN-817 starting at 0.25 mg bid up to 4.00 mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | 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 | Week 1-Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period | Percent change in 28-day frequency of quantifiable focal seizures during the 1-year Treatment Period relative to baseline | Baseline and Treatment Period (Week 1-52) |
| Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Supernus Clinical Trials | Contact | 240-403-5838 | clinicaltrials@supernus.com | |
| Navid Saeidi, MS | Contact | 240-403-5328 | nsaeidi@supernus.com |
| Name | Affiliation | Role |
|---|---|---|
| Maciej Gasior, MD, PhD | Supernus Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medsol Clinical Research Center | Recruiting | Port Charlotte | Florida | 33952 | United States |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Greater than or equal to 50% reduction in 28-day frequency of focal seizures during the 1-year Treatment Period relative to baseline. |
| Baseline and Treatment Period (Week 1-52) |
| Proportion of participants experiencing seizure freedom | 100% reduction in 28-day frequency of focal seizures during the Treatment Period relative to baseline | Baseline and Treatment Period (Week 1-52) |
| Percentage of seizure-free days over the 1-year SPN-817 Treatment Period | The number of seizure-free days reported for each participant divided by the total number of days with seizure data reported, multiplied by 100. | Week 1-Week 52 |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |