A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures
Key facts
- Where
- Budapest, MagyarországSee the site
- Phase
- 3. fázis
Where in Magyarország
- Semmelweis UniversityBudapest, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sk Life Science Inc.
- Trial code
- EU 2023-506688-32-00
- Record updated
- 2025. december 10.
- Original description
To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizuresRead full original descriptionShow less
To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures
Inclusion: "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: 1. The subject must have successfully completed the Double-blind Treatment Period in the Core study. 2. 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.".
Exclusion: "In addition to all the exclusion criterion established in YKP3089C025, subjects meeting any of the following criteria will be excluded from the study: 1. Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids. 2. 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.".