EUCTR2010-020345-27-IT进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, FOLLOW-UP STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFICACY OF BRIVARACETAM USED AS ADJUNCTIVE TREATMENT IN SUBJECTS AGED 16 YEARS OR OLDER WITH PARTIAL ONSET SEIZURES - ND
SCHWARZ BIOSCIENCES, INC A member of the UCB Group of Companies0 个研究点目标入组 766 人开始时间: 2011年5月19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
- 766
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
- •An Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved written informed consent
- •signed and dated by the subject or by parent(s) or legally acceptable representative. The consent form or a
- •specific assent form, where required, will be signed and dated by minors.
- •Male/female subject from 16 years or older. Subject under 18 years may only be included where legally
- •permitted and ethically accepted.
- •Subject completed the Treatment Period of N01358.
- •Subject for whom the Investigator believes a reasonable benefit from the long-term administration of BRV may
- •be expected.
- •Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral
- •oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subject with childbearing potential
- •are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at
- •least ethinylestradiol 30µg per intake (or ethinylestradiol 50µg per intake if associated with any strong enzyme
- •inducer [eg, carbamazepine, phenobarbital, primidone, phenytoin, oxcarbazepine, St. John’s Wort, rifampicin]),
- •monogamous relationship with vasectomized partner, or double-barrier contraception are acceptable methods.
- •The subject must understand the consequences and potential risks of inadequately protected sexual activity, be
- •educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator
- •of any potential change in status. Abstinence will be considered as an acceptable method of contraception if the
- •Investigator can document that the subject agrees to be compliant.
- •Subject/legally acceptable representative considered as reliable and capable of adhering to the protocol (eg, able
- •to understand and complete diaries and questionnaires), visit schedule, or medication intake according to the
- •judgment of the Investigator
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or
- •comparative drugs as stated in this protocol during the course of the core study
- •Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the
- •safety of the subject
- •Poor compliance with the visit schedule or medication intake in the previous BRV study
- •Planned participation in any other clinical study of another investigational drug or device during this study
- •Pregnant or lactating woman
- •Any medical condition which, in the Investigator’s opinion, warrants exclusion
研究者
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