NL-OMON55857已完成2 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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosed with Parkinson*s disease;
- •- At least 18 years of age;
- •- Predictable off periods totalling *2 h per waking day despite PD medications,
- •including oral levodopa taken at least four times daily;
- •- Recognisable off periods for themselves and others;
- •- Sufficiently large (measurable) difference between on and off state
- •- At least 2 years of levodopa use;
- •- At least 4 weeks on a stable medication scheme prior to inclusion;
- •- Able to perform spirometry; - Signed informed consent.
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;
- •- Prolonged QT-interval;
- •- Pregnancy or breast-feeding.
研究者
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