EUCTR2020-005344-27-ES进行中（未招募）1 期
Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial-onset (Focal) Seizures
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. 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 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)
- •2. Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039)
- •3. Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds [lb])
- •4. Have had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography (CT) within 5 years before Visit 1 that ruled out a progressive cause of epilepsy
- •5. For subjects new to Study YKP3089C040 during the 8 weeks prior to Visit 1, participants must have had at least 1 POS seizure. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS
- •6. 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 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 be counted as one of the 3 allowed AEDs, with the settings stable for at least 4 weeks prior to screening and maintain stable throughout the study.
- •7. Investigator believes subject could benefit from new or continued exposure to study drug
- •8. Subjects must continue to meet all of the inclusion criteria from the YKP3089C039 study
- •9. Subjects receiving felbamate as a concomitant AED must meet the following criteria:
- •a. Have an 18-month history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening/Baseline).
- •b. No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.
- •c. 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
- •Any potential exception to inclusion criteria allowing de minimis (clinically trivial and meaningless) variations must be approved by the medical monitor.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Females who are breastfeeding or pregnant at Screening or Baseline
- •2. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 2 years before Visit 1.
- •3. Have a history of status epilepticus that required hospitalization during the 6 months before Visit 1.
- •4. 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., significant suicide risk, including suicidal behavior and ideation within 6 months before Visit 1, current psychotic disorder, acute mania).
- •5. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2 (i.e., answering Yes to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) in participants aged 6 and above.
- •6. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however, those who have previously documented failed epilepsy surgery will be allowed.
- •7. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
- •8. Evidence of moderate or severe renal insufficiency as defined by estimated glomerular
- •filtration rates (eGFRs) of 31 to < 60 milliliters per minute (mL/min) and < 30 mL/min, respectively.
- •9. Evidence of significant active hepatic disease. Stable elevation of liver enzymes, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medication(s), will be allowed if they are less than 3 times the upper limit of normal (ULN).
- •10. Evidence of significant active hematological disease; white blood cell (WBC) count equal or less than 2500/µL (2.50 1E+09/liter [L]) or an absolute neutrophil count equal or less than 1000/µL (1.00 1E+09/L).
- •11. Subjects with Familial short QT syndrome
- •12. Clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as greater than 450 milliseconds (msec) or shortened corrected QT interval (QTc) defined as less than 340 msec.
- •13. Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- •14. Subject has a history of 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.
- •15. History of AED-associated rash that involved conjunctiva or mucosae.
- •16. History of more than one non-serious drug-related hypersensitivity reaction that required discontinuation of the medication.
- •17. Concomitant use of vigabatrin. Participants who took vigabatrin in the past must be off vigabatrin for at least 5 months before Visit 1 and with documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in a visual perimetry test.
- •18. 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 once within the 30 days prior to Visit 1 (Screening/Baseline).
- •19. A VNS implanted less than 5 months before Visit 1 or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study)
- •20. History of or a concomitant medical condition that in the opinion of the investigator(s)
研究者
相似试验
招募中
3 期
"Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Children with Partial-onset (Focal) Seizures "2023-506841-52-00Sk Life Science Inc.74
进行中（未招募）
1 期
Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Children with Partial-onset (Focal) SeizuresPartial onset (focal) seizuresMedDRA version: 26.1Level: LLTClassification code 10016843Term: Focal seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10039910Term: SeizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-005344-27-PLSK Life Science, Inc.140
招募中
1 期
Open-Label Safety and Efficacy Study of Cenobamate (YKP3089) in Children with Partial-onset (Focal) SeizuresCTIS2023-506841-52-00Sk Life Science Inc.180
进行中（未招募）
3 期
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) SeizuresPartial EpilepsyNCT05067634SK Life Science, Inc.140
进行中（未招募）
不适用
An Efficacy and 2-year Safety Study of Rosuvastatin in Children and Adolescents (aged from 6 to less than 18 years) with Familial (inherited) Hypercholesterolaemia (high level of cholesterol in blood)EUCTR2009-016492-29-Outside-EU/EEAAstraZeneca AB200