A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

Phase 1

• Conditions: Primary Generalized Tonic-Clonic Seizures; MedDRA version: 20.0Level: HLTClassification code 10018101Term: Generalised tonic-clonic seizuresSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002981-37-BG
• Lead Sponsor: SK Life Science, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-01
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

In addition to satisfying all the inclusion criterion established in YKP3089C025, each subject must meet the following inclusion criteria to be enrolled in the study:

The subject must have successfully completed the Double-blind Treatment Period in the Core study.

Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in
accordance with ICH guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 142
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

In addition to all the exclusion criterion established in YKP3089C025, subjects meeting any of the following criteria will be excluded from
the study:

Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.

Any significant changes to the subject’s medical history that, in the opinion of the Principal Investigator, could affect the subject’s safety or conduct of the study.

Any potential exception to the inclusion as well as exclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the Medical Monitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures;Secondary Objective: N/A;Primary end point(s): The primary endpoints are safety measures: the incidences of adverse events (AEs) and serious adverse events (SAEs); summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination, and electrocardiogram (ECG) findings.;Timepoint(s) of evaluation of this end point: N/A

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A