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Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
EU CTIS ID: 2024-514045-11-00
What this study is testing
The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects (ages 2 to less than 18) with partial-onset (focal) seizures following single and multiple-dosing.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of epilepsy with partial-onset 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 6 months prior to Study Day 1 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, including a history of treatment failure with at least 2 AEDs)
- Male or female subject, from age 2 to less than 18 years at the time of informed consent
- Minimum and maximum weights for cohorts IIa, IIb and III are as follows (Males and Females, 3-97 Percentile (i.e., Min-Max), Body Weight, kg). This will capture 94% of the weights of boys and girls of each age group to obtain an accurate estimate for dosing: a. cohort IIa - 16-63 kg b. cohort IIb - 13-28 kg c. cohort III - 10-20 kg
- Written informed consent signed by the subject, legal guardian, or legally authorized representative (LAR) prior to entering the study in accordance with the ICH GCP guidelines. Age-appropriate assent will be obtained for children and adolescents when the subject is cognitively able.
- Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before Study Day 1; A vagal nerve stimulator (VNS) will not be counted as one of the 3 allowable AEDs
- In the Investigator’s opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug
You likely can't join if
- Progressive neurological disease, including degenerative CNS diseases and progressive tumors
- Scheduled for surgery during the study
- Ketogenic diet or vagal nerve stimulation that has undergone alteration within 30 days of the Screening visit.
- Treatment with an investigational drug or device (other than VNS) ≤ 30 days before the Screening visit.
- Females who are breastfeeding or pregnant at Screening or Baseline or who are of reproductive age and do not agree to be abstinent or to use highly effective methods of contraception.
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before the Screening visit
See the full eligibility criteria
Who can join
- Diagnosis of epilepsy with partial-onset 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 6 months prior to Study Day 1 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, including a history of treatment failure with at least 2 AEDs)
- Male or female subject, from age 2 to less than 18 years at the time of informed consent
- Minimum and maximum weights for cohorts IIa, IIb and III are as follows (Males and Females, 3-97 Percentile (i.e., Min-Max), Body Weight, kg). This will capture 94% of the weights of boys and girls of each age group to obtain an accurate estimate for dosing: a. cohort IIa - 16-63 kg b. cohort IIb - 13-28 kg c. cohort III - 10-20 kg
- Written informed consent signed by the subject, legal guardian, or legally authorized representative (LAR) prior to entering the study in accordance with the ICH GCP guidelines. Age-appropriate assent will be obtained for children and adolescents when the subject is cognitively able.
- Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before Study Day 1; A vagal nerve stimulator (VNS) will not be counted as one of the 3 allowable AEDs
- In the Investigator’s opinion, parents or caregivers must be able to report accurate seizure assessments during the screening and study periods and subjects must be able to ingest study drug
- Subjects with an implanted vagal nerve stimulator will be allowed if the vagal nerve stimulator was implanted at least 5 months prior to Screening and the stimulator parameters have not been changed for 30 days prior to Screening.
- Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Screening and will remain stable for the duration of the study
What rules you out
- Progressive neurological disease, including degenerative CNS diseases and progressive tumors
- Scheduled for surgery during the study
- Ketogenic diet or vagal nerve stimulation that has undergone alteration within 30 days of the Screening visit.
- Treatment with an investigational drug or device (other than VNS) ≤ 30 days before the Screening visit.
- Females who are breastfeeding or pregnant at Screening or Baseline or who are of reproductive age and do not agree to be abstinent or to use highly effective methods of contraception.
- Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before the Screening visit
- Have a history of status epilepticus that required hospitalization during the 6 months before the Screening visit
- Have an unstable psychiatric diagnosis that may confound participants’ ability to participate in the study or that may prevent completion of the protocol-specified tests (e.g., in the judgement of the investigator, pose an appreciable risk for suicide, including suicidal behavior and ideation within 6 months before the Screening visit, current psychotic disorder, acute mania)
- Any suicidal ideation with intent or without a plan within 6 months before the Screening visit in participants aged 6 and above as determined by the CSSR-S, if able
- Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participant’s safety or interfere with study assessments
- Evidence of significant hematological disease; white blood cell (WBC) count equal or less than 2500/μL (2.50 1E+09/L) or an absolute neutrophil count equal or less than 1000/μL (1.00 1E+09/L)
- Evidence of clinically significant disease or any medical condition that would compromise the subject’s ability to safely complete the study including, but not limited to, hepatic or renal failure, ischemic disease, human immunodeficiency virus (HIV) infection, active sexually transmitted disease (STD), active viral hepatitis, or malignancy
- Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 msec or shortened corrected QT interval (QTc) defined as less than 350 msec
- Subject has a history or any serious drug-induced hypersensitivity reaction (including, but not limited to, Stevens Johnson syndrome, toxic epidermal necrolysis, or DRESS) or any drug-related rash requiring hospitalization.
- History or AED-associated rash that involved conjunctiva or mucosae
- History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication
- Concomitant use of phenytoin and clobazam as these drugs may influence cenobamate plasma exposure. Subjects who took phenytoin or clobazam in the past must be off these drugs for at least 30 days prior to Study Day 1.
- Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Study Day 1 and with documentation showing no evidence of vigabatrin-associated clinically significant abnormality in a visual perimetry test
- Concomitant use of felbamate, Subjects who took felbamate in the past must be off this drug for at least 30 days prior to Study Day 1.
- Use of potent enzyme-modifying drugs, including inhibitors of CYP enzymes (such as cimetidine, fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem, and HIV antivirals) and inducers of CYP enzymes (such as glucocorticoids, phenytoin, rifampin and St John`s Wort) in the previous 30 days prior to Study Day 1 of this study
- A history of intermittent use of rescue benzodiazepines (i.e., 1 to 2 doses over a 24-hour period is considered a 1-time rescue) more than twice within the 30 days prior to the Screening Visit.
- A VNS implanted less than 5 months before the Screening visit or changes in parameter less than 30 days before the Screening visit
- Positive urine screen of drugs of abuse (if not due to concomitant medication, e.g., benzodiazepines as hypnotics) for Cohort 1 subjects.
- Presence of Familial short QT syndrome or relevant replicated QTc interval (QTcF less than 340 msec or greater than 450 msec in males and greater than 470 msec in females) on electrocardiogram (ECG)
- Previous exposure to cenobamate or sensitivity/allergy to components of the tablets or oral suspension.
- History of anoxic episodes require resuscitation within 6 months before the Screening Visit, drug or alcohol dependency or abuse within approximately the last 2 years or use of illegal recreational drugs.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
- Consumption of grapefruit or grapefruit-containing products within 72 hours before Day 1 and 72 hours before the day of multiple dose PK sampling (Day 59 for Cohort I)
- Significant clinical laboratory abnormalities, including elevation of serum AST or ALT more than 2 times the upper limit or normal (ULN) for each age group.
- Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before Day 1
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.