NCT04557085

Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period. The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS). The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.

Detailed description

Subjects will undergo an 8-week Screening/Baseline Period to assess seizure frequency. Subjects with a high enough number of seizures will be randomized in a 1:1:1:1 ratio to receive placebo or cenobamate 100, 200, or 400 mg given once per day in the morning. Subjects will first enter the 18-week Titration Phase, during which the initial dose will be 12.5 mg/day or placebo. The dose of cenobamate will be increased in a double-blind fashion from 12.5 mg/day to 25 mg/day and 50 mg/day (or matching placebo) at 2-week intervals and then will be titrated by 50 mg/day (or matching placebo) every 2 weeks. After 18-week up-titration, subjects will enter the Maintenance Phase. During the Maintenance Phase, subjects are recommended to maintain their dose for 6 weeks. Subjects who have completed the Double-blind Treatment Period and who choose to participate in this OLE will enter an 18-week Double-blind Conversion Phase before starting the 34-week Open-label Maintenance Phase. Subjects who do not enroll into the OLE will enter a 5-week FU period. The primary objective of this study is to evaluate the efficacy of cenobamate as adjunctive therapy compared with placebo in subjects with POS. The secondary objectives of this study are: To evaluate the safety and tolerability of cenobamate in subjects with POS, to evaluate the effect of cenobamate in POS and in specified seizure types, and to assess blood plasma exposure of cenobamate in subjects with POS.

Conditions

• Partial Seizure
• Focal Seizure

Interventions

Type	Name	Description
DRUG	Cenobamate	Cenobamate tablets
DRUG	Placebo	Matching placebo tablets

Timeline

• Start date: 2021-03-08
• Primary completion: 2024-02-01
• Completion: 2025-03-01
• First posted: 2020-09-21
• Last updated: 2023-10-10

Locations

3 sites across 3 countries: China, Japan, South Korea