EUCTR2018-004456-38-ES进行中（未招募）1 期
An Open-Label Study with Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
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
- 100
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
入选标准
- •Subjects must meet all of the following criteria to be included in this study:
- •1. Male or female subject, from age 1 month to less than 18 years.
- •2. Have a diagnosis of epilepsy with a pediatric epileptic syndrome or epilepsy with POS with or without secondary generalization.
- •3. Subjects must have had equal or greater than 4 seizures over the 4-week interval prior to Visit 2.
- •4. Have had brain imaging before Visit 1 that ruled out a progressive cause of epilepsy.
- •5. Are currently being treated with stable doses of 1 to a maximum of 4 approved AEDs. Doses must be stable for at least 4 weeks (at least 2 weeks for subjects <6 months old) before Visit 1; only 1 EIAED out of the maximum of 4 AEDs is allowed.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •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
- •Subjects who meet any of the following criteria will be excluded from this study:
- •1. Females who are breastfeeding or pregnant at Screening or Baseline.
- •2. Females of childbearing potential who:
- •? Within 28 days before study entry, did not use a combination of a barrier method with a highly effective method of contraception.
- •? Do not agree to use a combination of a barrier method with a highly effective method of contraception.
- •3. Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before Visit 1.
- •4. Have a history of status epilepticus that required hospitalization during the 6 months before to Visit 1.
- •5. Have an unstable psychiatric diagnosis that may confound subjects’ ability to participate in the study or that may prevent completion of the protocol specified tests.
- •6. Any suicidal ideation with intent with or without a plan within 6 months before Visit 2.
- •7. Are scheduled or confirmed or both to have epilepsy surgery within 6 months after Visit 1.
- •8. Evidence of clinically significant disease that in the opinion of the investigator could affect the subject’s safety or interfere with the study assessments.
- •9. Evidence of moderate or severe renal insufficiency as defined by estimated glomerular filtration rates (eGFRs).
- •10. Evidence of significant active hepatic disease.
- •11. Evidence of significant active hematological disease.
- •12. Clinically significant ECG abnormality, including Fridericia prolonged corrected QT interval (QTcF) defined as greater than 450 msec.
- •13. Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
- •14. Multiple drug allergies or a severe drug reaction to AEDs, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- •15. Concomitant use of felbamate as an AED for less than 2 years or where the dose has not been stable for at least 8 weeks before Visit 1.
- •16. Concomitant or recent (within last 5 months before Visit 1) use of vigabatrin or any evidence of vigabatrin-associated clinically significant vision abnormality.
- •17. Benzodiazepines for any indications other than epilepsy prohibited from 1 month before Visit 1 and during the study.
- •18. A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before Visit 1 or changes in parameter less than 4 weeks before Visit 1 (or thereafter during the study).
- •19. On a ketogenic diet for which the diet is not stable regimen for at least 4 weeks before to Visit 1.
- •20. History of or a concomitant medical condition that in the opinion of the investigator would preclude the subject’s participation in a clinical study or compromise the subject’s ability to safely complete the study.
- •21. Use of perampanel within 30 days before Visit 1, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
- •22. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or gluc
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