EUCTR2009-011135-13-IT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 - ND
BIAL - PORTELA & C?, S.A.0 个研究点目标入组 900 人开始时间: 2010年9月23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
- 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): 1. Have signed an informed consent before undergoing any study-related activities. Subjects of Asian ancestry 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 by electroencephalogram (EEG) or imaging studies, within 12 months of Visit 1. 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, double-barrier contraception method 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, double-barrier contraception method 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Visit 1 (Days –1 to –7): 1. History of pseudo-seizures. 2. Seizures occurring only in clusters. 3. Subjects with a 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. History of schizophrenia or suicide attempt. 8. 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. 9. Previous use of ESL or CBZ. 10. Using mono-amine oxidase inhibitors (MAOIs), tricyclic antidepressants, nefazodone, or isoniazid. 11. Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants. 12. History of alcohol, drug, or medication abuse within the last 2 years. 13. Uncontrolled cardiac (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, hematological, or oncology disorder. 14. History of bone marrow depression. 15. History of hepatic porphyrias (e.g. acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda). 16. 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). 17. Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 (measured at Visit 1). 18. Subjects of Asian ancestry who test positive for the presence of the HLA-B*1502 allele. 19. Pregnancy or lactating. 20. 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. 21. 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): 22. 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, no more than twice a week, for an epileptic indication and as rescue medication during the =5-day drug-free period. 23. Using MAOIs, tricyclic antidepressants, nefazodone, or isoniazid. 24. Pregnancy. 25. Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject’s ability to comply with the study protocol.
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