EUCTR2004-002140-10-BE进行中（未招募）1 期
An open-label, multi-center, follow-up trial to evaluate long-term safety and efficacy of brivaracetam (ucb 34714) used as adjunctive treatment at a flexible dose up to a maximum of 200 mg/day in subjects aged 16 years or older suffering from epilepsy
CB Pharma S.A.0 个研究点目标入组 1,000 人开始时间: 2005年6月30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
- 1,000
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 IEC/IRB approved written informed consent signed and dated by the subject or legally acceptable representative(s). The consent form or a specific assent form will be signed and dated by minors, according to country-specific regulations.
- •Male/female subjects from 16 years or older. Subjects under 18 years may only be included where legally permitted and ethically accepted.
- •Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study. Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study.
- •Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected.
- •Female subjects with childbearing potential:
- •o POS/PGS subjects: Female subjects without childbearing potential (premenarcheal; 2 years postmenopausal; bilateral oophorectomy or ovariectomy; bilateral salpingectomy, complete hysterectomy; congenital sterility) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study participation (Intra Uterine Device; diaphragm with spermicide; male or female condom with spermicide; oral hormonal contraceptive; non-oral hormonal contraceptive medication; bilateral tubal ligation; monogamous relationship with vasectomized partner). In particular, oral or depot contraceptive treatment with at least 30 µg [or 50 µg if associated with carbamazepine (CBZ) or other strong enzyme inducing drugs] ethinylestradiol per intake must be used in conjunction with a barrier method. 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. Sexual inactivity might be accepted on a case-by-case basis according to the judgment of the Investigator.
- •o ULD subjects: Female ULD subjects without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. Oral or depot contraceptive treatment with at least 30 µg [or 50 µg ethinylestradiol per intake if associated with carbamazepine (or other strong enzyme inducers e.g. phenobarbital, primidone, oxcarbazepine)] must be used in conjunction with a barrier method. 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. Sexual inactivity might be accepted on a case-by-case basis.
- •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? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Numb
排除标准
- •Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject.
- •Poor compliance with visit schedule or medication intake in previous brivaracetam trial.
- •Participation in any clinical trial of another investigational drug or device during the study.
- •Pregnant or lactating woman.
- •If the Investigator has any medically valid reason to doubt the eligibility of a subject, the subject should not be included into the trial. If however, the Investigator has any other kind of doubts concerning the eligibility, he/she should consult the Sponsor’s Clinical Study Physician or representative for clarification.
研究者
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