EUCTR2013-005391-17-LV进行中（未招募）1 期
An Open-Label Study With an Extension Phase to Evaluate thePharmacokinetics of Perampanel (E2007) Oral Suspension When Given as an Adjunctive Therapy in Subjects From 1 Month to Less Than 4 years of Age With Epilepsy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
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. Male or female, from =1 month to < 4 years) of age (and of at least 36 weeks gestational age) at the time of consent
- •2. Have a minimum weight of 4 kg (8.8 lb)
- •3. Have a diagnosis of epilepsy with any type of seizure according to the ILAE guidelines: International League Against Epilepsy’s Classification of Epileptic Seizures (1981). Diagnosis should have been established at least 2 weeks (=6 months of age) or 4 weeks (>6 months of age) before Visit 1, by clinical history and an electroencephalogram (EEG) that is consistent with epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
- •4. Have had brain imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) before Visit 1 that ruled out a progressive cause of epilepsy
- •5. Have had 1 or more seizure(s) before Visit 1
- •6. Are currently being treated with a stable dose (ie, unchanged for at least 5 half-lives) of 1 to a maximum of 3 AEDs (At least 6, but not more than 8 subjects will be taking 1 EIAEDs [ie, CBZ, OXC, PHT, or ESL] out of the maximum of 3 AEDs allowed. The remaining subjects cannot be taking any EIAEDs)
- •7. Have been on their current concomitant AED(s) with a stable dose for at least 2 weeks or 5 half-lives, whichever is longer, before Visit 1
- •8. Must have discontinued all restricted medications at least 2 weeks or 5 half-lives (whichever is longer) before Visit 1
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 17
- •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. Have a history of status epilepticus that required hospitalization during the 3 months before Visit 1
- •2. Have seizures due to treatable medical conditions, such as those arising due to metabolic disturbances, toxic exposure, or an active infection
- •3. Have epilepsy secondary to progressive central nervous system (CNS) disease or any other progressive neurodegenerative disease, including tumors
- •4. Have had epilepsy surgery within 1 year of Visit 1
- •5. Are scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1
- •6. Used intermittent rescue benzodiazepines (ie, 1 to 2 doses over a 24-hour period considered one-time rescue) 2 or more times in the 2 weeks before Visit 1
- •7. Prior use of felbamate
- •8. Prior use of vigabatrin
- •9. Are on a ketogenic diet that has not been stable for at least 4 weeks before Visit 1
- •10. Have used other drugs known to influence the CNS, where the dose has not been stabilized for at least 2 weeks (=6 months of age) or 4 weeks (>6 months of age) before Visit 1
- •11. Have any concomitant illnesses/co-morbidities that could severely affect the subject’s safety or study conduct
- •12. Have evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator(s) could affect the subject’s safety or study conduct
- •13. Have clinically significant laboratory abnormalities or any clinically acute or chronic disease
- •14. Have 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 limits of normal (ULN)
- •15. Have clinical evidence of significant active hematological disease; white blood cell (WBC) count =2500/µL (2.50 x 10^9/L) or an absolute neutrophil count =1000/µL (1.00 x 10^9/L)
- •16. Have conditions that may interfere with their participation in the study and/or with the PK of study drug
- •17. Have participated in a study involving administration of an investigational drug or device within 4 weeks before Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer
- •18. Have previously participated in a clinical trial involving perampanel
- •19. Have a clinically significant electrocardiogram (ECG) abnormality, including prolonged corrected QT interval (QTc) defined as > 450 msec
- •20. Have had multiple drug allergies or a severe drug reaction to an AE(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions
研究者
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