Cenobamate Expanded Access Program (EAP)

Status Approved for marketing

Clinical Trial 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 clinical trial YKP3089C013, YKP3089C017 or YKP3089C021.

Clinical Trial 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 be sponsored by SK Life Science Inc. and managed by WEP Clinical. Cenobamate is approved for the treatment of partial onset seizures in adults in United States. The attached US Label (appendix 1) provides the most recent guidance for use of cenobamate. The objective of this EAP is to continue providing treatment with Cenobamate (YKP3089) to patients with partial-onset epilepsy that were enrolled in the SK Life Science clinical trial YKP3089C013, YKP3089C017 or YKP3089C021. Access to Cenobamate under this guideline is considered a treatment scenario and is not a clinical trial. Epilepsy is a symptom of a neurological problem that causes sudden, brief seizures. It leads to an increased risk of injury from accidents, an increased rate of mortality, and has a significant impact on quality of life. Epilepsy can occur as a result of a neurological injury, a structural brain lesion, as a part of many systemic medical diseases or may be generic in origin. The incidence of having epilepsy during a lifetime is between 2-5%. Available medications control seizures in 50% of patients and decrease seizure incidence in 75%. The remainder continued to have unacceptable number of seizures, side effects, and psychiatric symptoms. The high treatment failure may be the result of inadequate efficacy or intolerable side effects that lead to poor compliance. Cenobamate is a novel small molecule that is an antiepileptic agent for partial onset seizures. The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04513860
Study type	Expanded Access
Source	SK Life Science, Inc.
Contact
Status	Approved for marketing
Phase

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.