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

Sponsor
SK Life Science, Inc.
Study ID
NCT04557085
Phase
PHASE3
Status
Completed

Conditions

  • Focal Seizure
  • Partial Seizure

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cenobamate — DRUG
    Cenobamate tablets
  • Placebo — DRUG
    Matching placebo tablets

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Oct 2023
Primary completion
Feb 16, 2024
Completion
Mar 21, 2025

Study Design

Enrollment
519 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo
  • Experimental: Cenobamate 100 mg/day
    Cenobamate 100 mg/day
  • Experimental: Cenobamate 200 mg/day
    Cenobamate 200 mg/day
  • Experimental: Cenobamate 400 mg/day
    Cenobamate 400 mg/day

Primary Outcome Measure

Percent change from baseline in seizure frequency (seizure rate per 28-day interval) of all simple partial motor, complex partial, or secondarily generalized seizures during the Maintenance Phase. [ Time Frame: per 28 days during 6 week maintenance phase ]

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