NCT06798896

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

RENAISSANCE 2: a 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 2 double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 administered as an adjunctive treatment in adults with focal onset seizures that have previously failed at least 2 anti-seizure medication (ASM) regimens. Participants will be taking 1 to 4 ASMs, with at least 4 seizures during the 6-week Screening Period. Following the Screening Period, eligible participants will be randomized 2:1 to SPN-817 (3.0-4.0 mg BID) or placebo and begin the Titration Period (8-10 weeks). In both treatment groups, open-label ondansetron (8 mg oral \[PO\]) will be taken prophylactically approximately 30 minutes before each SM dose (ie, BID) during the first 5 weeks of dose titration as an antiemetic; after the first 5 weeks, ondansetron may be taken as needed as either a preventative or therapeutic antiemetic. After the target dose of 3.0-4.0 mg BID is reached, participants will enter the Maintenance Period (14 weeks). Participants who complete the Maintenance Period will have the opportunity to enroll in a separate open-label study for continued treatment with SPN-817. Participants who do not enroll in the open-label study will undergo a Tapering Period (up to 4 weeks) and a follow-up safety phone call.

Conditions

• Focal Onset Seizures

Interventions

Type	Name	Description
DRUG	SPN-817	SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
DRUG	Placebo	Placebo, bid

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2025-01-29
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study