Cenobamate Open-Label Extension Study for YKP3089C025

Launched by SK LIFE SCIENCE, INC. · May 21, 2019

Keywords

ClinConnect Summary

This trial is a 52-week open-label safety study of cenobamate used as an add-on (adjunctive therapy) for people with primary generalized tonic-clonic seizures in the setting of idiopathic generalized epilepsy. It follows a previous core study and is designed to look mainly at safety over the long term rather than proving whether cenobamate works better than another treatment. After a 12-week period where people who had received placebo in the core study are gradually switched to cenobamate, everyone will receive cenobamate with a planned maximum daily dose of 200 mg. The first 12 weeks involve steadily increasing the dose to reach 200 mg, and the last two weeks maintain that dose to keep the blind in the core study intact. Then there are about 40 weeks of open-label treatment, where doctors can adjust the dose between 50 mg and 200 mg based on safety and how well the medicine is tolerated. Adolescents get the same plan, but as a liquid suspension based on their weight.

To be eligible, people must be 12 years or older and must have completed the core study’s double-blind period. Participants must sign informed consent (and assent when appropriate) and meet the study’s safety criteria; healthy volunteers are not eligible. Exclusion includes a positive urine drug screen for illicit drugs (other than cannabis) and any medical history changes that could affect safety or study conduct. The study is ongoing at many sites around the world, led by SK Life Science, and its main goal is to monitor long-term safety through regular assessments like lab tests, vital signs, neuro exams, and ECGs. If you are considering this, talk with your clinician about whether an open-label safety extension like this is appropriate for you or your loved one.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.