Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Part of paid clinical trials in Jacksonville, Florida.
- Sponsor
- Supernus Pharmaceuticals, Inc.
- Study ID
- NCT05518578
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Epilepsy
- Seizures, Epileptic
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- SPN-817 — DRUGoral capsule
Study Details
This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures
Key Dates
- Start date
- Feb 7, 2023
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Open-Label Treatment0.25 mg to 4 mg SPN-817 taken orally twice daily
Primary Outcome Measure
Effects of SPN-817 on safety and tolerability [ Time Frame: 72 weeks ]
Central Contacts
- Supernus Clinical Trials240-403-5838
- Navid Saiedi, MS240-403-5328
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Green Leaf Clinical Trials, LLC | Jacksonville | Florida | 32258 | - |
| Visionary Investigators Network | Miami | Florida | 33133 | - |
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