EUCTR2019-000696-16-BG进行中（未招募）1 期
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects with Schizophrenia
Sumitomo Pharma America, Inc. (SMPA)0 个研究点目标入组 612 人开始时间: 2019年7月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 612
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
- •Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
- •Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 57
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 555
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject answered yes” to suicidal ideation” Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the EOT Visit of Study SEP361-301 or SEP361-302.
- •Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
研究者
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