NCT02162979终止2 期
A Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Duration of Dyskinesia.
研究概览
简要总结
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.
详细描述
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease.
- Age > 40 years.
- willingness and ability to comply with the study requirements and give informed consent.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.
- •Presence of drug-induced dyskinesias
- •Age>40 years.
- •Willingness and ability to comply with the study requirements and give informed consent.
排除标准
- •Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
- •History of stereotaxic brain surgery.
- •Clinical history of dementia.
- •Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
- •History of major hematological, renal, or hepatic abnormalities.
- •Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
- •History of stroke within the last 6 months.
- •Abnormal EKG consistent with cardiac ischemia.
- •Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
- •Malignant hypertension or SBP . 180 or <90, or DBP .110 or <
- •History of priapism.
- •Known history of retinitis pigmentosa.
- •Positive pregnancy test.
- •History of bleeding disorder.
- •Patients with active peptic ulcer disease associated with bleeding.
- •Unwillingness to use adequate contraceptive methods if of childbearing potential.
- •Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
- •Use of Viagra or any experimental drugs within 30 days of screening visit.
研究组 & 干预措施
Viagra
Experimental
subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
干预措施: sildenafil (Drug)
Placebo comparator
Placebo Comparator
subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Duration of Dyskinesia.
时间窗: 2 weeks
次要结局
- Percent Change in "on" Time(4 weeks)
- Change in Dose of Anti-parkinsonian Medications(7 weeks)
研究者
研究点 (1)
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