EUCTR2017-004006-18-NL进行中（未招募）1 期
Therapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease
Pharmaceutical Technology and Biopharmacy, University of Groningen0 个研究点目标入组 8 人开始时间: 2017年11月15日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 8
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
- •- Diagnosed with Parkinson’s disease;
- •- At least 18 years of age;
- •- Predictable off periods;
- •- Recognisable off periods for themselves and others;
- •- Sufficiently large (measurable) difference between on and off state (10 points on UPDRS III scale);
- •- At least 2 years of levodopa use;
- •- Able to perform spirometry;
- •- Signed informed consent.
- •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 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
- •- Current treatment with apomorphine or duodopa by pump;
- •- Severe off periods during the night;
- •- Current or past experience with depression/depressed mood;
- •- Known symptomatic orthostatic hypotension;
- •- Active pulmonary disease;
- •- Pregnancy or breast-feeding.
研究者
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