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Anti-epileptic drug
Cenobamate (Xcopri) for Seizures
Phase 1
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
Male or female subjects, from age 2 to less than 18 years at the time of informed consent
Minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial will look at how a new seizure medication works in children.
Who is the study for?
This trial is for children and teens aged 2 to less than 18 with epilepsy characterized by partial-onset seizures. They must have been diagnosed at least 6 months prior, weigh over 10 kg, be on a stable dose of up to two antiepileptic drugs (excluding vagal nerve stimulators), and not have significant health issues like heart problems or severe infections.Check my eligibility
What is being tested?
The study tests the drug Cenobamate (YKP3089) in young patients with epilepsy to understand how the body processes it after one dose and multiple doses. It aims to find out how much of the drug gets into the bloodstream and how long it stays there.See study design
What are the potential side effects?
While specific side effects are not listed here, similar medications can cause drowsiness, dizziness, fatigue, coordination difficulties, changes in behavior or mood, allergic reactions or skin rashes. The trial will monitor for these and other potential adverse effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 17 years old.
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I weigh at least 22 pounds.
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I have epilepsy with partial-onset seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri
The maximum plasma concentration (Cmax) after a single and multiple doses of Xcopri
Secondary outcome measures
Safety - adverse events (AEs) reporting after a single and multiple doses of Xcopri
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: Cohort IIbExperimental Treatment1 Intervention
Xcopri to be administered to ages 4 to < 6 years not to exceed 400 mg/day.
Group II: Cohort IIaExperimental Treatment1 Intervention
Xcopri to be administered to ages 6 to < 12 years not to exceed 400 mg/day.
Group III: Cohort IIIExperimental Treatment1 Intervention
Xcopri to be administered to ages 2 to < 4 years not to exceed 400 mg/day.
Group IV: Cohort IExperimental Treatment1 Intervention
Xcopri to be administered to ages 12 to < 18 years not to exceed 400 mg/day.
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Who is running the clinical trial?
SK Life Science, Inc.Lead Sponsor
40 Previous Clinical Trials
8,823 Total Patients Enrolled
14 Trials studying Epilepsy
4,175 Patients Enrolled for Epilepsy
Marc Kamin, MDStudy DirectorSK Life Science, Inc.
9 Previous Clinical Trials
2,307 Total Patients Enrolled
4 Trials studying Epilepsy
537 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a rash from taking certain seizure medications that also affected your eyes or mouth.You had to stop taking a medication because you had a bad reaction to it more than once.My white blood cell count is low, or I have very few infection-fighting cells.You can still join if you've been on a ketogenic diet for at least 30 days before the first visit and will continue this diet during the study.I have not had thoughts of harming myself in the last 6 months.Your blood tests show that the levels of certain enzymes, AST or ALT, are more than double the normal range for your age group.I am between 2 and 17 years old.I weigh at least 22 pounds.I am on 1 or 2 stable epilepsy drugs, not counting a VNS.My ECG shows a QT interval outside the normal range.You have a significant abnormality in your heart's electrical activity, as shown on an ECG test.I do not have any major health issues that could make it unsafe for me to participate in the study.I am not pregnant or breastfeeding, and if of childbearing age, I agree to use effective birth control.Your urine test shows that you have used drugs that are not prescribed to you.I do not have any health issues that could affect how a drug works in my body.I do not have any major health issues that could affect my safety in the study.I haven't taken vigabatrin for 5 months and my eye test after stopping it was normal.I have epilepsy with partial-onset seizures.You have had a severe allergic reaction to a medication in the past that caused a serious skin condition or required a hospital stay.I have used emergency anxiety medication more than twice in the last month.If you have a device called a vagal nerve stimulator, it must have been implanted at least 5 months before the study starts, and the settings on the device must not have been changed for the month before the study and during the study.You had a VNS implanted less than 5 months ago, or the settings on your VNS were changed less than 30 days ago.I haven't taken phenytoin or clobazam for at least 30 days.I am scheduled for surgery during the study period.I was hospitalized for a severe seizure within the last 6 months.I have had pseudo-seizures in the last 5 years.I haven't consumed caffeine or alcohol 72 hours before Day 1 and Day 59.You have eaten grapefruit or products with grapefruit in them within 72 hours before the start of the study and before certain days when blood samples will be taken.I was diagnosed with my condition over 6 months ago and have had an EEG.I haven't had symptoms like nausea, fever, or diarrhea in the last week.I have not changed my ketogenic diet or vagal nerve stimulation in the last 30 days.My neurological condition is getting worse over time.You have a mental health condition that may make it hard for you to take part in the study or complete the required tests. This includes a recent history of suicidal thoughts or behavior, current psychotic disorder, or acute mania.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort III
- Group 2: Cohort IIb
- Group 3: Cohort I
- Group 4: Cohort IIa
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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