EUCTR2008-001329-33-CZ进行中（未招募）1 期
Open-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AbbVie Inc
- 入组人数
- 275
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
- •In order to be eligible to participate in this study, subjects must meet the following criteria:
- •1. The subject should have completed participation in Study S187.3.003, S187.3.004, or any new Phase 3 open-label LCIG study initiated by the Sponsor; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. For Canada, subjects will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
- •2. The subject must understand the nature of the study and must provide written
- •informed consent prior to the conduct of any study related procedures.
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 138
排除标准
- •Subjects meeting any of the exclusion criteria listed below at baseline must be excluded from participation in the study.
- •1. Medical, laboratory, psychiatric, or surgical issues deemed by the Investigator to be clinically significant, and which could confound the findings of the study, or interfere with the subject’s participation in the study.
研究者
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