RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures

Part of paid clinical trials in Port Charlotte, Florida.

Sponsor
Supernus Pharmaceuticals, Inc.
Study ID
NCT06798896
Phase
PHASE2
Status
Recruiting
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Conditions

  • Focal Onset Seizures

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures.

Key Dates

Start date
Dec 30, 2024
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPN-817
    SPN-817, bid
  • Placebo Comparator: Placebo
    Placebo, bid

Primary Outcome Measure

Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period [ Time Frame: Baseline and Maintenance Period (Maintenance Week 1-14) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medsol Clinical Research CenterPort CharlotteFlorida33952
Maria Vasconcelos, RN
[email protected]
941-623-9744

Find similar trials in Port Charlotte, FL

By research site
Medsol Clinical Research Center· Port Charlotte, FL

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