Clinical trial
A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures
Name
YKP3089C033
Description
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
Trial arms
Trial start
2019-08-13
Estimated PCD
2025-05-01
Trial end
2025-11-01
Phase
Early phase I
Treatment
Cenobamate
active drug
Arms:
Core Study Active, Core Study Placebo
Other names:
YKP3089
Size
145
Primary endpoint
Incidence of Adverse Events and SAEs
386 +/- 2 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 145, 'type': 'ESTIMATED'}}
Updated at
2024-04-05
1 organization
1 product
1 indication
Organization
SK Life ScienceProduct
Cenobamate