EUCTR2017-000230-62-Outside-EU/EEA进行中（未招募）1 期
A Phase III study of M071754 - A single-blind study in patients with infantile spasms.
Alfresa Pharma Corporation and Sanofi KK0 个研究点目标入组 12 人开始时间: 2017年4月24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
- 12
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
- •Patients (aged >=4 weeks, <2 years) diagnosed with infantile spasms manifested by spasms and hypsarrhythmia on electroencephalography. Using classification of ILAE 1989
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) no
- •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
- •- Patients with concurrent severe liver/renal disease, cardiac disease, serious gastrointestinal disorder.
- •- Patients who received adrenocorticotropic hormone (ACTH) products or steroids within 4 weeks (28 days prior to the formal registration of this study.
- •- Patients previously or currently treated with vigabatrin.
- •- Patients who have concurrent or a history of ophthalmological complication in whom possible aggravation of the symptoms with vigabatrin.
- •- Patients with concomitant Lennox-Gastaut syndrome.
研究者
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