NCT00623363已完成2 期
A Double-Blind, Placebo-Controlled, Preliminary Study of the Efficacy, Safety, and Tolerability of Intravenous SUN N4057 in Patients With Motor Complications Associated With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 7
- 主要终点
- Change From Baseline in the Percentage of "On" Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo
研究概览
简要总结
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease for at least 5 years
- •Presence of motor fluctuations and dyskinesia
- •Stable regimen of levodopa/carbidopa for 30 days
- •At least 25% response/improvement in Unified Parkinson's Disease Rating Scale (UPDRS) part III scores after dosing with regular Parkinson's disease (PD) medications
- •Mini-Mental State Examination (MMSE) score of 25 or higher
排除标准
- •Atypical or secondary parkinsonism.
- •Prior use of neuroleptic agents.
- •History of intracranial procedures for PD.
- •Active psychosis.
- •History of drug or alcohol abuse in past 12 months.
- •Cardiac conduction system abnormality.
- •Predisposing medical condition that causes nausea or vomiting or routine use of an anti-emetic.
研究组 & 干预措施
piclozotan
Active Comparator
Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days.
干预措施: piclozotan (Drug)
0.9 % sodium chloride (normal saline)
Placebo Comparator
Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a plasma level of 30 ng/mL over 2 inpatient days.
干预措施: 0.9% sodium chloride (normal saline) (Drug)
结局指标
主要结局
Change From Baseline in the Percentage of "On" Time Without Dyskinesia Averaged Over Days 1 and 2 in Participants Treated With SUN N4057 and Those Treated With a Placebo
时间窗: Baseline (Day-7) up to 2 days post-dose.
Improvement in motor complications associated with Parkinson's disease are measured as "on" (good medication response); OR "on with dyskinesia" (good medication response, but with superimposed involuntary movements that interfere with activities), OR "off" (poor medication response).
次要结局
- Change From Baseline up to Day 2 in the Percentage of "on" Time Without Dyskinesia, as Assessed Over Hours 1 to 8 for Each Time Point in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Percentage of "on" Time With Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Percentage of "on" Time With or Without Dyskinesia at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1 and Day 2 post-dose.)
- Percentage of "Off" Time at Baseline up to Day 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Change From Baseline up to Day 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Mean SUN N4057 Plasma Concentrations Over Time Following Treatment With SUN N4057(Day 1 pre-dose (Hour 0), 1 hour, 6 hours, 12 hours; Day 2 pre-dose (Hour 24), 1 hour (Hour 25), 6 hours (Hour 30), 12 hours (Hour 36), and Day 3 Hour 0 (Hour 48) post-dose.)
- Percentage of "on" Time With Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Percentage of "on" Time With or Without Dyskinesia for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1 and Day 2 post-dose.)
- Percentage of "Off" Time for the Average of Days 1 and 2, and the Change From Baseline in Participants Treated With SUN N4057 and Those Treated With a Placebo(Baseline (Day -7), Day 1, and Day 2 post-dose.)
- Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Minimum Concentration (Cmin) Following Treatment With SUN N4057(Day 1 pre-dose (Hour 0) up to Hour 24, and Hour 48 post-dose.)
- Average of Days 1 and 2 in the Average Abnormal Involuntary Movement Scale (AIMS) Total Score in Participants Treated With SUN N4057 and Those Treated With a Placebo(Day 1 and Day 2 post-dose.)
- Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Maximum Concentration (Cmax) Following Treatment With SUN N4057(Baseline (Day 1 pre-dose) up to Hour 24, and Hour 48 post-dose.)
- Mean SUN N4057 Plasma Pharmacokinetic Parameter of Observed Mean Concentration (Caverage) Following Treatment With SUN N4057(Day 1 at 1 hour, 6 hours, and12 hours; Day 2 at 25 hours, 30 hours, and 36 hours post-dose.)
- Mean SUN N4057 Pharmacokinetic Parameter of Area Under the Drug Concentration vs Time Curve (AUCt) Following Treatment With SUN N4057(Baseline (Day 1 pre-dose) up to Hour 0, Hour 1, Hour 6, Hour 12, Hour 24, Hour 25, Hour 30, Hour 36, and Hour 48 post-dose.)
- Treatment-Related Treatment-Emergent Adverse Events Reported Following Treatment With SUN N4057 or Placebo(Baseline up to Day 16 post-dose, up to approximately a total 12 months.)
研究者
研究点 (7)
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