Status:
APPROVED_FOR_MARKETING
Cenobamate Expanded Access Program (EAP)
Lead Sponsor:
SK Life Science, Inc.
Conditions:
Partial Epilepsy
Eligibility:
All Genders
18-65 years
Brief Summary
This Cenobamate Expanded Access Program (EAP) is designed to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science cl...
Detailed Description
This Expanded Access Program (EAP) is designed to provide access to an unlicensed drug that is approved in the United States for the treatment of a serious or life-threatening condition. This EAP will...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients currently enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021.
- Patient who is currently pregnant and enrolled in one of the following SK life science studies: YKP3089C013, YKP3089C017 or YKP3089C021 may enter the EAP program.
- Written informed consent signed by the patient or legal guardian prior to entering the EAP in accordance with the ICH GCP guidelines. If the written informed consent is provided by the legal guardian because the patient is unable to do so, a written or verbal consent from the patient must also be obtained.
- EXCLUSION CRITERIA
- 1\. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04513860
Last Update
January 26 2022
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