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Completed NCT03961568

Cenobamate Open-Label Extension Study for YKP3089C025

Conditions: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 147
Sponsor: SK Life Science, Inc.

Location: University of California, San Diego (UCSD) La Jolla California

Summary

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03961568). StuddyBuddy aggregates publicly available trial information.