NCT01229332已完成1 期
A Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence and frequency of adverse events, withdrawal rate
研究概览
简要总结
A cross-over study, where ND0611 or placebo will be tested on top of 3 different LD/CD dosage forms. Safety and tolerability, pharmacokinetic profile of levodopa and carbidopa and the potential clinical effect of ND0611 will be explored in subjects with PD and motor fluctuations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with idiopathic Parkinson's disease
- •Subjects must experience motor fluctuations associated with LD/CD dosing
- •Modified Hoehn and Yahr stage < 5
- •Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
- •Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
- •Subjects must be age 30 or older.
- •Subjects must be willing and able to give informed consent.
排除标准
- •Subjects with a clinically significant or unstable medical or surgical condition
- •Subjects with clinically significant psychiatric illness.
- •Pre-menopausal women, not using birth control method.
- •Subjects who have taken experimental medications within 60 days prior to baseline.
- •Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Saline (Drug)
Carbidopa
Placebo Comparator
干预措施: Carbidopa (Drug)
结局指标
主要结局
Incidence and frequency of adverse events, withdrawal rate
时间窗: Up to 2 days
1. Incidence and frequency of adverse events, of dopaminergic adverse events 2. Adverse events reporting related to the ND0611 Omnipod® application, Draize score 2. Withdrawal rates and discontinuations due to adverse events
次要结局
- Half life (t½ ), Cmax, Tmax and AUC of levodopa and carbidopa in the plasma(Up to 2 days)
研究者
研究点 (1)
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