Partial EpilepsyNCT04513860
Cenobamate Expanded Access Program (EAP)
A study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- YKP3089
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.
About this study
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.
Read the 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 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.
- Conditions
- Partial Epilepsy
- Being tested
- YKP3089
- Keywords
- Partial onset seizures, Treatment resistant, Partial epilepsy
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKP3089Drug
Also called Cenobamate
Capsule, dose to be titrated Tablet, dose to be titrated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- SK Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Kamin, MD, Study director, SK Life Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513860
- Sponsor's protocol ID
- C013, C017, C021 EAP
- Status last verified
- Jan 2022
- First submitted
- 4 Aug 2020
- Last updated
- 26 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cenobamate Expanded Access Program (EAP)
- ClinicalTrials.gov ID
- NCT04513860
- Acronym / sponsor ID
- C013, C017, C021 EAP
- Conditions
- Partial Epilepsy
- Keywords
- Partial onset seizures, Treatment resistant, Partial epilepsy
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- SK Life Science, Inc.Industry (pharma, biotech, devices)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Patients that have previously discontinued for any reason from studies YKP3089C013, YKP3089C017 and YKP3089C021.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YKP3089Also: CenobamateCapsule, dose to be titrated Tablet, dose to be titrated | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
Related trials for Partial Epilepsy
Enrolling by invitationPhase 2
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Active, not recruitingPhase 4
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
Focal Onset Seizure
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Surgery as a Treatment for Medically Intractable Epilepsy
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Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kamin, MD study director
SK Life Science, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing YKP3089 in people with Partial Epilepsy, run by SK Life Science, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.