临床试验/NCT04086810

NCT04086810撤回3 期

An Open-Label Study of Diazoxide Choline Controlled-Release Tablet in Patients With Prader-Willi Syndrome

Soleno Therapeutics, Inc.0 个研究点开始时间: 2019年10月最近更新: 2021年8月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 撤回
发起方: Soleno Therapeutics, Inc.
主要终点: Adverse Events (Safety)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The primary objective of this study is to monitor the long-term safety of DCCR in PWS patients.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 4 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Successful completion of clinical study C602, Visit 15
•Provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate)
•Primary caregiver must be able to communicate with Investigator and study site personnel as well as read and complete the study-required questionnaires.

排除标准

•Positive urine pregnancy test (in females of childbearing potential)
•Females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation
•Any new disease, condition, or circumstance, which may significantly impact subject safety

研究组 & 干预措施

DCCR

Experimental

25 - 450 mg DCCR

干预措施: DCCR (Drug)

结局指标

主要结局

Adverse Events (Safety)

时间窗: Baseline to Week 106

Assess the safety of DCCR by evaluating the incidence and severity of adverse events reported.

次要结局

未报告次要终点

研究者

发起方

Soleno Therapeutics, Inc.

申办方类型

Industry

责任方

Sponsor

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