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 (NCT06798896)

This proposed study 817P203, is a Phase 2 double-blind, randomised, placebo-controlled, multicentre, parallel-group study to evaluate the efficacy, safety, and tolerability of SPN-817 in adults with focal onset seizures. The study is planned to involve approximately 258 participants aged 18 to 70 years who have focal onset seizures at multiple study sites worldwide in the United States, Europe, and Asia Pacific. The study will have two groups of participants will be randomly assigned in a 2:1 ratio to SPN-817 (3.0 to 4.0 mg twice daily [BID]) or placebo, respectively, to achieve approximately 180 participants globally completing the study. The duration of treatment with SPN-817 or placebo will be approximately 22 to 24 weeks. The Primary Objective is to evaluate the efficacy of SPN-817 as a treatment for adult participants with focal onset seizures. The Secondary Objectives are to evaluate the safety and tolerability of SPN-817 as a treatment for adult participants with focal onset seizures, and to characterize the pharmacokinetics (PK) of huperzine A after multiple dose administrations of SPN-817 (population PK analysis).

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Diagnosis of treatment-resistant focal epilepsy as adjudicated by the Epilepsy Study Consortium, Inc (ESCI); Failed to achieve sustained seizure freedom after ?2 tolerated, appropriately chosen, and adequately dosed ASM drug schedules; Adults aged 18 to ? 70 years at screening; Able to read, understand, and sign the Informed Consent Form (ICF). If the participant is unable to provide informed consent, a Legally Authorized Representative (LAR) may complete the ICF.