跳至主要内容
临床试验/NCT03196934
NCT03196934No Longer Available不适用

A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

MultiCare Health System Research Institute0 个研究点开始时间: 2017年6月23日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
No Longer Available
发起方

研究概览

简要总结

To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

详细描述

To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.

研究设计

研究类型
Expanded Access

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Completed the Insys 030 protocol
  • •Compliant in drug study procedures
  • •Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended

排除标准

  • •Failure to follow study procedures in Insys 030
  • •Pregnant females

研究者

发起方
MultiCare Health System Research Institute
申办方类型
Other
责任方
Sponsor

相似试验

Expanded Use of Cannabidiol Oral Solution | 临床试验