ong-Term Eslicarbazepine Acetate Extension Study - n/a

Sunovion Pharmaceuticals Inc.0 个研究点目标入组 348 人2010年10月19日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Sunovion Pharmaceuticals Inc.
入组人数: 348
状态: 进行中（未招募）
最后更新: 8年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2010年10月19日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Sunovion Pharmaceuticals Inc.

入排标准

入选标准

•1\. Subject who completed, exited, or discontinued for reasons other than safety from the 18\-week treatment phase of Protocols 093\-045 or 093\-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18\-week double\-blind treatment period of Protocols 093\-045 or 093\-046 to be eligible.
•2\. Subject must give written informed consent prior to participation in the study. For subjects \<18 years of age, the informed consent must be signed by the subject’s parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (\=65 years of age) must also sign the Women of Childbearing Potential” Addendum.
•3\. Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
•4\. If female subject, must continue the accepted method of birth control defined in Protocols 093\-045 or 093\-046 for the duration of this study as well.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range

排除标准

•1\. Subject who completed, exited, or discontinued for reasons other than safety from the 18\-week treatment phase of Protocols 093\-045 or 093\-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18\-week double\-blind treatment period of Protocols 093\-045 or 093\-046 to be eligible.
•2\. Subject must give written informed consent prior to participation in the study. For subjects \<18 years of age, the informed consent must be signed by the subject’s parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (\=65 years of age) must also sign the Women of Childbearing Potential” Addendum.
•3\. Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
•4\. If female subject, must continue the accepted method of birth control defined in Protocols 093\-045 or 093\-046 for the duration of this study as well.