Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures (NCT04903314) | Clinical Trial Compass
CompletedPhase 1
Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
United States26 participantsStarted 2021-05-27
Plain-language summary
The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.
Who can participate
Age range2 Years – 18 Years
SexALL
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Inclusion criteria
✓. 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 Visit 1 by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allows 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 subjects, from age 2 to less than 18 years at the time of informed consent
✓. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds \[lb\])
✓. 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. If the written informed consent is provided by the legal guardian or LAR because the subject is unable to do so, a written or verbal assent from the subject must also be obtained
✓. Are currently being treated with stable doses of 1 to a maximum of 2 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. A vagal nerve stimulator (VNS) will not be counted as one of the 2 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 Visit 1 (Screening) and the stimulator parameters have not been changed for 30 days prior to Visit 1 and for the duration of the study
Exclusion criteria
✕. Progressive neurological disease, including degenerative CNS diseases and progressive tumors
✕. 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
✕. Positive urine screen of drugs of abuse (if not due to concomitant medication, e.g., benzodiazepines as hypnotics) for Cohort 1 subjects.
✕. History of anoxic episodes require resuscitation within 6 months before Visit 1, 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.
What they're measuring
1
The area under the curve (AUC) of Xcopri after a single and multiple doses of Xcopri
Timeframe: 18 Months
2
The maximum plasma concentration (Cmax) after a single and multiple doses of Xcopri
. Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study