EUCTR2018-002981-37-SKActive, not recruitingPhase 1
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- SK Life Science, Inc.
- Enrollment
- 145
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
- •An age-appropriate assent will be obtained for adolescents.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •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
- •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.
Investigators
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