EUCTR2004-000152-16-ES进行中（未招募）1 期
An international open-label extension trial to determine safety and efficacy of longterm oral SPM 927 in patients with partial seizuresEnsayo de extensión, internacional y abierto, para determinar la seguridad y la eficacia de la administración oral a largo plazo de SPM 927 en pacientes con crisis parciales.
SCHWARZ BIOSCIENCES GmbH0 个研究点目标入组 376 人开始时间: 2005年5月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 376
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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