EUCTR2007-005440-25-Outside-EU/EEA进行中（未招募）不适用
A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects with Partial-onset Seizures
CB BIOSCIENCES, Inc.0 个研究点目标入组 294 人开始时间: 2013年7月16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
- 294
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
- •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 entered the Maintenance Phase of the double-blind trial, SP902 (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902.
- •3. Subject is expected to benefit from participation in an open-label extension trial with LCM, 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: 44
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 221
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •1. Subject is receiving any investigational drugs or using any experimental devices in addition to LCM.
- •2. Subject meets the withdrawal criteria (excluding exit criteria) for the previous trial (SP902) or is experiencing an ongoing serious adverse event (SAE).
研究者
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