EUCTR2008-002455-25-FR进行中（未招募）1 期
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS ADJUNCTIVE THERAPY FOR REFRACTORY PARTIAL SEIZURES IN A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAL.
BIAL - Portela & Cª, SA0 个研究点目标入组 360 人开始时间: 2008年6月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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:
- •*Written informed consent signed by patient and by parents or legal guardian if the patient is an adolescent between 16_18 years old, and written assent form signed by the adolescent
- •*Aged 16 years or more;
- •*Documented diagnosis of epilepsy for at least 12 months prior to screening
- •*At least 4 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) on the 4-weeks prior to screening
- •*Currently treated with 1 or 2 AEDs (any except oxcarbazepine), in a stable dose regimen during at least 1 month prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified, and a confirmatory test should be available within 1 month before study entry
- •*If present, vagus nerve stimulation [VNS] is considered an AED, i.e., only up to 1 concomitant AED is allowed in patients with VNS); excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination
- •(PE) and clinical laboratory tests
- •*Post-menopausal women or female patients otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential (WOCBP), patient must present a serum ß-human chorionic gonadotropin
- •(ß-hCG) test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (hormonal contraception should be combined with a barrier method) beginning at screening and continuing at least to the post-study visit.
- •-At visit 2 (randomisation), patient must have
- •*At least 4 partial-onset seizures per 4 weeks during the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 21 consecutive days
- •*In case of WOCBP, patient must present a urine ß-hCG test consistent with a non-gravid state; diaries satisfactorily completed by the patient or his/her caregiver
- •*Satisfactorily complied with the study requirements during the baseline period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-At visit 1 (screening), patients must not be / have:
- •*Only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures)
- •*Primarily generalised seizures
- •*Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive cerebral lesion)
- •*Occurrence of seizures too close to count accurately
- •*History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
- •*Seizures of nonepileptic origin
- •*Major psychiatric disorders; seizures of psychogenic origin within the last 2
- •*History of schizophrenia or suicide attempt; currently treated with oxcarbazepine
- •*Using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
- •*Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate
- •*Known hypersensitivity to carbamate derivatives; history of abuse of alcohol, drugs or medications within the last 2 years
- •*Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
- •*Second or third-degree atrioventricular blockade not corrected with a pacemaker
- •*Relevant clinical laboratoryabnormalities (e.g., Na+ <130 mmol/L, alanine or aspartate transaminases [ALT or AST] >2.0 times the upper limit of the normal [ULN], white blood cell count [WBC] <3,000 cells/mm3)
- •Estimated creatinine clearance (CLCR) <60 mL/min; pregnancy or nursing
- •*Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whichever is longer
- •*Not ensured capability to perform the trial; 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:
- •*Inadequate compliance to concomitant AEDs during the 8-week baseline period
- •*Inadequate completion of the study diary
- •*Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient’s ability to comply with the study protocol.
研究者
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