临床试验/JPRN-jRCT2080222507

JPRN-jRCT2080222507未知3 期

A Phase III study of M071754 - A single-blind study in patients with infantile spasms

Alfresa Pharma Corporation0 个研究点目标入组 12 人开始时间: 2014年6月2日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
发起方: Alfresa Pharma Corporation
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 至 <= 1age old（—）
性别: All

入选标准

•Patients diagnosed with infantile spasms manifested by spasms and hypsarrhythmia on electroencephalography

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

发起方

Alfresa Pharma Corporation

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