NCT05518578

Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

RENAISSANCE Study: A Phase 2, Multicenter, Open Label Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of SPN-817 in adults with treatment resistant seizures

Detailed description

This is a multicenter, three-phase, long-term open-label study assessing the safety and tolerability of SPN-817 in adults 18-70 years of age with treatment resistant epilepsy. The Screening period is up to 8 weeks in duration. For eligible participants, Treatment period is 20 weeks in duration followed by an optional Open-Label Extension period which is up to 52 weeks in duration.

Conditions

• Epilepsy
• Seizures, Epileptic

Interventions

Type	Name	Description
DRUG	SPN-817	oral capsule

Timeline

• Start date: 2023-02-07
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2022-08-26
• Last updated: 2023-03-20

Locations

1 site across 1 country: Australia