CTIS2023-507794-17-00招募中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 - E2007-G000-236
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 89
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Male or female subject, from age 1 month to less than 18 years for Cohort 1, or age 1 month to less than 2 years for Cohort 2 at the time of informed consent/assent. Subjects below the age of 1 year must have been at least 36 weeks of gestational age at birth. (revised per Amendments 01 and 02), Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2) according to the International League against Epilepsy (ILAE) Classification of Epileptic Seizures (1981). The eligibility criteria for the 2 cohorts are not mutually exclusive as a subject may experience POS as part of an epilepsy syndrome; these subjects are eligible for Cohort 1 if: (1) they are 2 to less than 18 years of age; or (2) they are 1 month to less than 2 years of age AND Cohort 2 is filled. Diagnosis must have been established by clinical history and an EEG that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)., Subjects must have had equal or greater than 4 seizures over the 4-week interval prior to Visit 2. For Cohort 1, all seizures except simple POS without motor signs are counted toward this inclusion. For Cohort 2, only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS., Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (eg, magnetic resonance imaging [MRI] scan, computed tomography [CT], or ultrasound [only for subjects <1 year old]). (revised per Amendment 02)., Are currently being treated with stable doses of 1 to a maximum of 4 approved AEDs. A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for subjects <6 months old) before Visit 1; only 1 enzyme-inducing AED (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed. (revised per Amendment 01).
排除标准
- •Females who are breastfeeding or pregnant at Screening/Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the 1st dose of study drug., Evidence of significant active hepatic disease. Stable elevation of liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) due to concomitant medications, will be allowed if they are less than 3 times the upper limit of normal (ULN)., Evidence of significant active 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)., Clinically significant ECG abnormality, including Fridericia prolonged corrected QT interval (QTcF) defined as greater than 450 msec., Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors., Multiple drug allergies or a severe drug reaction to AEDs, including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions., 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. They must not have a history of WBC count below equal or less than 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests above 3 times the ULN, or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If subjects received felbamate in the past, it must have been discontinued 8 weeks before Visit 1 to be eligible for study participation., Concomitant or recent (within last 5 months before Visit 1) use of vigabatrin or any evidence of vigabatrin-associated clinically significant vision abnormality., Benzodiazepines for any indications other than epilepsy (eg, anxiety/sleep disorders) prohibited from 1 month before Visit 1 and during the study. Benzodiazepines for seizure control and as rescue medication are allowed. (revised per Amendments 01 and 02), 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)., On a ketogenic diet for which the diet is not stable regimen for at least 4 weeks before Visit 1., 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, which includes any of the following: (revised per Amendment 01) o Total abstinence (if it is their preferred and usual lifestyle). o An intrauterine device or intrauterine hormone-releasing system (IUS). o A contraceptive implant. o An oral contraceptive (with additional barrier method). Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation. o Have a vasectomized partner with confirmed azoospermia. Do not agree to use a combination of a barrier method with a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation. (revised per Amendment 01). For site
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