Cenobamate Expanded Access Program (EAP)
Cenobamate Expanded Access Program (EAP)
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.
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.
INCLUSION CRITERIA

 1. Patients currently enrolled in one of the following SK life science studies:
 YKP3089C013, YKP3089C017 or YKP3089C021.

 2. 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.

 3. 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.