EUCTR2004-002140-10-ES进行中（未招募）1 期
An open-label, multicenter, follow-up trial to evaluate long-term safety and efficacy ofucb 34714 used as adjunctive treatment at a flexible dose up to a maximum of 150 mg/day in subjects aged 16 years or older suffering from partial onset seizures
CB S.A. Pharma Sector0 个研究点目标入组 1,000 人开始时间: 2005年9月16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 Independent Ethic Committee (IEC) 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.
- •? Inpatients or outpatients with partial onset seizures who were treated with ucb 34714 in previous trials / programs which allow access to the present trial.
- •?Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of ucb 34714 may be expected.
- •?Female subjects without childbearing potential (premenarcheal; 2 years post-menopausal; 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 trial 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)] ethinylestradiol per intake 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.
- •? Subject/legally acceptable representative considered as reliable and capable of
- •adhering to the protocol (e.g.; 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
- •?Severe medical, neurological and psychiatric disorders, or laboratory values which
- •may have an impact on the safety of the subject.
- •? Subject having clinically significant deviations from reference range values for
- •laboratory parameters: creatinine clearance < 50 mL/min, platelets < 100,000/?l, or
- •neutrophil cells < 1,800/?l).
- •ucb 34714 / N01125 CONFIDENTIAL
- •Protocol RPCE03D0801 Final amended version / 01-Apr-2005 / Page 38 of 91 A
- •? Poor compliance with visit schedule or medication intake in previous ucb 34714 trial.
- •? Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, ?GT
- •value of more than three times the upper limit of the reference range.
- •? Participation in any clinical trial of another investigational drug or device during the
- •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 CRP or representative for clarification.
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