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

Epilepsy Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05518578
Study type Interventional
Source Supernus Pharmaceuticals, Inc.
Contact Neeti Mehta, PhD
Phone 240-403-5838
Email namehta@supernus.com
Status Recruiting
Phase Phase 2
Start date February 7, 2023
Completion date January 2025
View Details
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