EUCTR2008-005606-39-PL进行中（未招募）1 期
Effects of Eslicarbazepine acetate (BIA 2-093) on cognitive function in children with partial onset seizures: an add-on, double-blind, randomised, palcebo-controlled, parallel-group, multicenter clinical trial - NA
BIAL - Portela & Cª, SA0 个研究点目标入组 117 人开始时间: 2009年10月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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 Visit1 (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.
- •4.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.
- •5.An IQ of at least 70 within the 1 year prior to screening.
- •6.A parent or legal representative able to understand and willing to complete the CBCL and CHQ throughout the study.
- •7.Current treatment with 1 to 2 AEDs (any except oxcarbazepine).
- •8.Excepting epilepsy, judged to be in general good health based on medical history, physical examination and clinical laboratory tests.
- •9.In the opinion of the investigator, able to complete the CDR test battery.
- •10.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:
- •11.At least 2 partial-onset seizures during the 4-week baseline period prior to randomisation (documented in a diary).
- •12.In case of a girl of childbearing potential, patient presents a urine ß-hCG test consistent with a non-gravid state.
- •13.Stable dose regimen of concomitant AEDs during the 4 week baseline period.
- •14.Diaries satisfactorily completed by the patient or his/her caregiver during the baseline period.
- •15.Satisfactory compliance with the study requirements during the baseline period.
- •At OL7, the patient will be evaluated for eligibility into the Part III additional 2-year open-label extension. Assessments at this visit will be considered baseline values for Part III
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 18
- •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 Visit1 (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. Documented and established diagnosis of Attention-Deficit Hyperactivity Disorder (ADHD) currently treated with stimulants or history of other diseases adversely affecting cognitive abilities (if stable ADHD and not treated with stimulants patients can be included).
- •13. Currently treated with oxcarbazepine.
- •14. Occasional use of benzodiazepines for any reason other than epilepsy.
- •15. On ketogenic diet.
- •16. Receiving VNS
- •17. Known hypersensitivity to carboxamide derivatives (oxcarbazepine or carbamazepine).
- •18. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
- •19. Second or third degree atrioventricular blockade.
- •20. Relevant clinical laboratory abnormalities.
- •21. Estimated creatinine clearance (CLCR) <60 mL/min.
- •22. Pregnancy or nursing.
- •23. Treatment with ESL in any previous study.
- •24. Participation in other drug clinical trial within the last 2 months.
- •25. Not ensured capability to perform the trial.
- •26. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.
- •At Visit 2 (randomisation), patients must not be / have:
- •27.Any 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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