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SPN-817

Phase 2

Focal Onset Seizures | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: Jun 1, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment316
FDA Designations
No designations recorded
Clinical trial landscape

SPN-817 · 3 trials · 3 indications

Phase 2 3
NCT07141329SPN-817 Open-Label Extension Study in Adults With Focal Onset SeizuresFocal Onset Seizures
RECRUITING100 Analytics
NCT06798896RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset SeizuresFocal Onset Seizures
RECRUITING216 Analytics
NCT05518578Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant EpilepsyEpilepsy
RECRUITING60 Analytics
PHASE2RECRUITING
SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
Focal Onset Seizures
NCT07141329100
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PHASE2RECRUITING
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
NCT06798896216
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PHASE2RECRUITING
Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy
Epilepsy
NCT0551857860
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Study Endpoints
Primary Endpoints
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

Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period
Baseline 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

Effects of SPN-817 on safety and tolerability
72 weeks

The incidence of adverse events.

Secondary Endpoints
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)
Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Baseline and Treatment Period (Week 1-52)
Proportion of participants experiencing seizure freedom
Baseline and Treatment Period (Week 1-52)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SPN-817EXPERIMENTALSPN-817, bid
PlaceboPLACEBO_COMPARATORPlacebo, bid
Open-Label TreatmentEXPERIMENTAL0.25 mg to 4 mg SPN-817 taken orally twice daily
Interventions
NameTypeDescription
SPN-817DRUGSPN-817 starting at 0.25 mg bid up to 4.00 mg bid
PlaceboDRUGPlacebo, bid
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 t...

Countries:United StatesAustralia
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
LOWMay 26, 2026NCT07141329primaryCompletionDate: changed
LOWMay 26, 2026NCT06798896primaryCompletionDate: changed
LOWMay 24, 2026NCT07141329studyFirstPostDate: changed
LOWMay 24, 2026NCT06798896studyFirstPostDate: changed