EUCTR2008-005606-39-NL进行中（未招募）不适用
EFFECTS OF ESLICARBAZEPINE ACETATE (BIA 2-093) ON COGNITIVE FUNCTION IN CHILDREN WITH PARTIAL ONSET SEIZURES: AN ADD-ON, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTRE CLINICAL TRIA
BIAL-Portela & Ca, SA0 个研究点目标入组 117 人开始时间: 2009年7月13日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 117
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
- •At Visit 1 (screening), patient must be / have:
- •1.Written informed consent signed by parent or legal representative and, where applicable, the patient.
- •2.Aged 6 to 16 years, inclusive.
- •3.A documented diagnosis of epilepsy for at least 12 months prior to screening. At least 2 partial onset seizures during the 4 weeks prior to screening despite treatment with 1 to 2 AEDs in a stable dose regimen.
- •4.An IQ of at least 70.
- •5.Current treatment with 1 to 2 AEDs (any except oxcarbazepine, benzodiazepines other than clobazam and VNS).
- •6.Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
- •7.In the opinion of the investigator, able to complete the CDR test battery.
- •8.In case of a girl of childbearing potential, patient presents a serum ß-hCG test consistent with a non gravid state and agrees to remain abstinent or use reliable contraception (if used, hormonal contraception must be combined with a barrier method) starting at screening and continuing until at least the PSV.
- •At Visit 2 (randomisation), patient must have:
- •9.At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary).
- •10.In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state.
- •11.Stable dose regimen of concomitant AEDs during the 4 week baseline period.
- •12.Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period.
- •13.Satisfactory compliance with the study requirements durign the baseline period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •At Visit 1 (screening), patients must not be / have:
- •1.Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
- •2.Primarily generalised seizures.
- •3.Known rapidly progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
- •4.Occurrence of seizures too close together to count accurately.
- •5.History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
- •6.Seizures of non-epileptic origin.
- •7.Lennox-Gastaut syndrome.
- •8.West syndrome.
- •9.Major psychiatric disorders.
- •10.Seizures of psychogenic origin within the last 2 years.
- •11.History of schizophrenia or suicide attempt.
- •12.History of attention deficit disorder or other diseases adversely affecting cognitive abilities.
- •13.Currently treated with oxcarbazepine, benzodiazepines other than clobazam (on a routine or chronic basis) and/or VNS.
- •14.Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine).
- •15.Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
- •16.Second or third degree atrioventricular blockade.
- •17.Relevant clinical laboratory abnormalities.
- •18.Estimated creatinine clearance (CLCR) <60 mL/min.
- •19.Pregnancy or nursing.
- •20.Treatment with ESL in any previous study.
- •21.Participation in other drug clinical trial within the last 2 months.
- •22.Not ensured capability to perform the trial.
- •23.Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.
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