EUCTR2007-005440-25-IT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 - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
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:
- •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
- •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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