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Anti-epileptic drug
Cenobamate for Epilepsy
Phase 3
Recruiting
Research Sponsored by SK Life Science, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.
Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial will test the safety and tolerability of cenobamate in children with partial-onset (focal) seizures.
Who is the study for?
This trial is for children aged 2-17 with partial-onset seizures and a stable epilepsy diagnosis. They must weigh at least 10 kg, have had an MRI or CT scan within the last 10 years, be on a steady dose of up to three antiepileptic drugs (excluding VNS), and may also be on a ketogenic diet. Pregnant or breastfeeding females, those with certain psychiatric conditions, significant diseases, recent investigational drug use, specific genetic intolerances or severe renal/hepatic insufficiency are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Cenobamate (Xcopri) in young patients with focal seizures. It aims to see how well they tolerate this medication and if it helps control their seizures better than their current treatment regimen.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects likely include central nervous system-related symptoms such as dizziness or fatigue; gastrointestinal issues like nausea; possible allergic reactions; blood cell count changes; liver enzyme alterations; and other drug-specific adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had liver or blood problems from taking felbamate.
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I have been diagnosed with epilepsy that starts in one area of my brain for over a year.
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I have been taking felbamate for at least a year and have been on a stable dose for the last 60 days.
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I am between 2 and 17 years old and can give consent.
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I weigh at least 22 pounds.
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I am on 1 to 3 stable epilepsy drugs and not counting a VNS, which has also been stable.
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I am taking felbamate as part of my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events and SAEs
Secondary outcome measures
Acceptability and palatability assessment (determined by a 5-point Hedonic Scale) of the oral formulation and tablets
To collect plasma samples of cenobamate to support the evaluation of the pharmacokinetics of cenobamate tablets and suspension in pediatric subjects with partial onset (focal) seizures
Side effects data
From 2021 Phase 2 trial • 222 Patients • NCT0139796822%
Somnolence
22%
Dizziness
12%
Nausea
12%
Headache
11%
Fatigue
10%
Nystagmus
8%
Balance disorder
8%
Urinary tract infection
7%
Upper respiratory tract infection
6%
Tremor
6%
Nasopharyngitis
5%
Vomiting
5%
Diarrhea
5%
Constipation
1%
Status epilepticus
1%
Anxiety
1%
Drug hypersensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
YKP3089
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: 6 to <12 years oldExperimental Treatment1 Intervention
Group II: 4 to <6 years oldExperimental Treatment1 Intervention
Group III: 2 to <4 years oldExperimental Treatment1 Intervention
Group IV: 12 to < 18 year oldsExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,707 Total Patients Enrolled
14 Trials studying Epilepsy
4,175 Patients Enrolled for Epilepsy
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,191 Total Patients Enrolled
4 Trials studying Epilepsy
537 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've used emergency anxiety medication more than once in the last month.I have been diagnosed with Familial Short QT Syndrome.I have a rare hereditary sugar intolerance condition.I only have seizures that don't affect my movement or are generalized.I have never had liver or blood problems from taking felbamate.You have a heart condition that shows up on an ECG test, like a prolonged or shortened QT interval.I haven't taken vigabatrin for 5 months and my eye test after stopping it was normal.I have been diagnosed with epilepsy that starts in one area of my brain for over a year.I have been taking felbamate for at least a year and have been on a stable dose for the last 60 days.I am scheduled for epilepsy surgery within 6 months, or I had an unsuccessful epilepsy surgery before.My liver is generally healthy or has stable enzyme levels not more than 3 times the normal limit.You have had a severe allergic reaction to a medication in the past that caused a serious skin condition or required hospitalization.You have stopped taking a medication in the past because of a non-serious allergic reaction more than once.You have had a rash caused by a specific type of medication that affected your eyes or mucous membranes.I am between 2 and 17 years old and can give consent.I weigh at least 22 pounds.If you are new to Study YKP3089C040, you must have had at least one specific type of seizure in the 28-day period before starting the study.I am on 1 to 3 stable epilepsy drugs and not counting a VNS, which has also been stable.I have never taken cenobamate or am allergic to its ingredients.I do not have any major health issues that could affect my safety in the study.I was hospitalized for a severe seizure within the last 6 months.I am not pregnant or breastfeeding.I have had pseudo-seizures in the last 2 years.You have a low white blood cell count or neutrophil count, which shows that you have a significant blood-related illness.I am taking felbamate as part of my treatment.You have had thoughts about wanting to harm yourself in the past 6 months.My kidney function is moderately or severely reduced.My condition involves worsening brain or nerve disease or a growing brain tumor.I haven't had a VNS implant or its settings changed within the last 5 months.You can follow a ketogenic diet as long as you've been doing it for at least 30 days before the first visit and will continue to do so during the study.
Research Study Groups:
This trial has the following groups:- Group 1: 2 to <4 years old
- Group 2: 12 to < 18 year olds
- Group 3: 6 to <12 years old
- Group 4: 4 to <6 years old
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the requirements to be eligible for this test?
"The team conducting this trial is looking for 140 participants that have gelastic epilepsy and are between 2 and 18 years old."
Answered by AI
Are octogenarians able to join this research project?
"Children aged 2 to 18 years-old are eligible for this clinical trial, with 47 similar studies available for patients under 18 and 78 for those over 65."
Answered by AI
Are there any other instances in the medical literature of Xcopri being used?
"At the moment, there are 5 independent studies being conducted for Xcopri. Out of those 5, 4 are in Phase 3. Although the majority of these tests are being done in Memphis, Tennessee, there are 148 other locations where these trials are running."
Answered by AI
How many research participants are included in this experiment?
"Recruitment for this clinical trial is currently paused. The study was originally posted on January 14th, 2022 with the last update on October 11th, 2022. However, if you are looking for other studies, there are 102 studies actively admitting participants with gelastic epilepsy and 5 trials for Xcopri actively admitting patients."
Answered by AI
Are research participants still being recruited for this project?
"Unfortunately, this study is no longer admitting patients. The trial was first posted on 1/14/2022 and saw its last update on 10/11/2022. If you are interested in other trials, there are 102 trials for gelastic epilepsy and 5 trials for Xcopri that are still admitting patients."
Answered by AI
In how many settings is this research project being conducted?
"Prior mentioned, this study is enrolling patients at Duke University Hospital in Durham, North carolina, Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland, and Phoenix Children's Hospital in Phoenix, Arizona. In addition, there are 5 other recruitment centres."
Answered by AI
Could you please outline the risks associated with taking Xcopri?
"There is existing clinical evidence for the efficacy of Xcopri as well as data from multiple rounds of safety trials, so it received a score of 3."
Answered by AI
Do we have any previous case studies to compare this to?
"SK Life Science, Inc. first conducted a Phase 3 clinical trial for Xcopri in 152 patients back in 2018. Since then, there have been 7 completed trials across 10 countries and 49 cities."
Answered by AI
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