EUCTR2009-011135-13-HU进行中（未招募）1 期
EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES: A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
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
- •Visit 1 (Days –1 to –7; Screening)
- •1. Have signed an informed consent before undergoing any study-related activities. Subjects of Asian ancestry (subjects with a direct ancestor of Asian origin, irrespective of the generational difference) are required to give written informed consent for genotyping.
- •2. Male or female =18 years of age.
- •3. Newly diagnosed epilepsy with at least 2 well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) with clear focal origin, documented clinically OR by electroencephalogram (EEG) OR imaging studies, within 12 months of Visit 1. In this context, seizures that occur within a period of 48 hours are counted as 1 seizure.
- •4. At least 1 seizure during the previous 3 months.
- •5. Demonstrated cooperation and willingness to complete all aspects of the study.
- •6. Female subjects without childbearing potential (2 years postmenopausal, bilateral oophorectomy or tubal ligation, or complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative serum beta-human chorionic gonadotropin (hCG) test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the Post-study visit (PSV).
- •Visit A1 (Day 1; Randomization and start of double-blind treatment period)
- •7. Have satisfactorily completed the electronic subject diary (eDiary).
- •8. Female subjects with childbearing potential must not be pregnant as confirmed by a negative urine pregnancy test and sexually active females must be using a medically acceptable effective non-hormonal method of contraception for the duration of the study and until the PSV.
- •Are the trial subjects under 18? no
- •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 750
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Visit 1 (Days –1 to –7; Screening)
- •1. History of pseudo-seizures.
- •2. Seizures occurring only in clusters.
- •3. History of absence, myoclonic, clonic, tonic, or atonic seizures.
- •4. Documented EEG within 12 months of Visit 1 suggestive of primarily generalized epilepsy.
- •5. History of status epilepticus within the 3 months prior to Visit 1.
- •6. Known progressive neurologic disorder (progressive brain disease, epilepsy secondary to progressive cerebral lesion) as assessed by magnetic resonance imaging or computer tomography.
- •7. Former or current use of any AED, except for the use of a single AED for a maximum duration of 2 weeks before Visit 1.
- •8. Previous regular use of ESL or CBZ (previous use as acute treatment for seizures in an emergency situation is not an exclusion criterion).
- •9. Using mono-amine oxidase inhibitors (MAOIs), tricyclic antidepressants, nefazodone, isoniazid, or protease inhibitors or any other anti-retroviral agents (e.g. efavirez) that may raise the levels of CBZ-CR.
- •10. Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
- •11. History of uncontrolled psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months, a history of suicide attempt, schizophrenia, chronic treatment with benzodiazepines (except short-acting benzodiazepines) or barbiturates.
- •12. Judged clinically to have a suicidal risk in the opinion of the investigator based upon a clinical interview and the Columbia Suicide-Severity Rating Scale (C-SSRS).
- •13. History of alcohol, drug, or medication abuse within the last 2 years.
- •14. Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, hematological, or oncology disorder.
- •15. History of bone marrow depression.
- •16. History of hepatic porphyrias (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda).
- •17. Relevant clinical laboratory abnormalities (e.g. sodium <130 mmol/L, alanine or aspartate transaminases >2 x the upper limit of normal, white blood cell count <3000 cells/mm3) (measured at Visit 1).
- •18. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (measured at Visit 1).
- •19. Subjects of Asian ancestry who test positive for the presence of the HLA-B*1502 allele.
- •20. Pregnancy or lactating.
- •21. Participation in other drug clinical trial within the last 2 months or having received an IMP within 5 half-lives of that IMP, whichever is longer.
- •22. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
- •Visit A1 (Day 1; Randomization and start of double-blind treatment period)
- •23. Former or current use of any AED *, except for the use of a single AED for a maximum duration of 2 weeks before Visit 1 and with a drug-free period of at least 5 days before Visit A1. Benzodiazepines are allowed for an epileptic indication and as rescue medication during the =5-day drug-free period.
- •24. Using prohibited medication.
- •25. Pregnancy.
- •26. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
- •*For clarification, an acute treatment for a seizure during the study (e.g. in the emergency room) is allowed and is not considered a deviation.
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