EUCTR2008-002455-25-GR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: 2009年2月18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
相似试验
进行中（未招募）
不适用
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093)AS THERAPY FOR PATIENTS WITH PAINFUL DIABETIC NEUROPATHY:A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAadult patients with painful diabetic neuropathyMedDRA version: 9.1Level: PTClassification code 10012680Term: Diabetic neuropathyEUCTR2007-002461-12-PTBIAL - Portela & Ca, S.A.540
进行中（未招募）
1 期
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURESAdult patients with newly diagnosed partial-onset seizuresMedDRA version: 18.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852EUCTR2009-011135-13-CZBIAL - Portela & Ca, S.A.900
进行中（未招募）
不适用
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093)AS THERAPY FOR PATIENTS WITH PAINFUL DIABETIC NEUROPATHY:A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIAadult patients with painful diabetic neuropathyMedDRA version: 9.1Level: PTClassification code 10012680Term: Diabetic neuropathyEUCTR2007-002461-12-CZBIAL - Portela & Ca, S.A.540
已完成
3 期
A Phase III clinical trial to evaluate the Efficacy and Safety profile of Eslicarbezepine acetate as monotherapy in patients with partial onset SeizuresCTRI/2011/08/001959BIAL Portela Ca SA900
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.simple partial seizures with no motor symptomatology EpilepsyMedDRA version: 9.1Level: LLTClassification code 10065336Term: Partial epilepsyEUCTR2008-002455-25-FRBIAL - Portela & Cª, SA360