SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures

Part of paid clinical trials in Port Charlotte, Florida.

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT07141329
Phase
PHASE2
Status
Recruiting

Conditions

  • Focal Onset Seizures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SPN-817 — DRUG
    SPN-817 starting at 0.25 mg bid up to 4.00 mg bid

Study Details

This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.

Key Dates

Start date
Jul 30, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SPN-817
    SPN-817, bid

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: Week 1-Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medsol Clinical Research CenterPort CharlotteFlorida33952
Maria Vasconcelos, RN
941-623-9744

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