EUCTR2004-000152-16-LT进行中（未招募）不适用
An international open-label extension trial to determine safety and efficacy of long-term oral SPM 927 in patients with partial seizures
SCHWARZ BIOSCIENCES GmbH; A member of the UCB group0 个研究点目标入组 577 人开始时间: 2004年10月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 577
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
- •Subjects must fulfill the following inclusion criteria:
- •1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •2. Subject has completed the Maintenance and Transition Phases of the clinical trial, SP755, for the treatment of partial seizures.
- •3. Subject is expected to benefit from participation, in the opinion of the investigator.
- •4. Subject is willing and able to comply with all trial requirements.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- •1. Subject is receiving any investigational drugs or using any experimental devices in addition to SPM 927.
- •2. Subject meets the withdrawal criteria for the previous trial (SP755) or is experiencing an ongoing serious adverse event.
研究者
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