EUCTR2007-005033-11-DE进行中（未招募）不适用
A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- Patients who have provided written informed consent which is written in a manner approved by the Institutional Review Board/Ethics Committee
- •- At least 65% of the subjects should be male
- •- Ambulatory patients who are 58 to 75 years of age. The study population will consist of patients with a diagnosis of idiopathic Parkinson disease and will meet both of the following criteria:
- •1.PD, defined with at least two of the following cardinal features: rest tremor, bradykinesia, rigidity with PD diagnosis less than or equal to 5 years.
- •2.Levodopa-responsive idiopathic Parkinson’s disease (PD) patients receiving carbidopa/levodopa (immediate release or sustained-release forms (or both), optimally managed with levodopa intake of no more than 600 mg/day.
- •-Evaluable patients will need to have levodopa-induced peak-effect dyskinesias.
- •- Female patients must not be of childbearing potential (e.g., surgically sterile or be at least one year post-menopausal).
- •- Patients must be willing and able to abide by the dietary requirements of the study
- •- Patients must be willing and able to abide by the restrictions on concomitant medication use that are outlined (restrictions to be determined-see section 9.6).
- •- Patients must be willing to cooperate with study procedures and to be confined within the clinical site’ designated facility overnight, including three consecutive nights.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Clinical evidence of other parkinsonian syndromes, other than Parkinson’s disease (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, lewy body dementia).
- •-Patients with the dyskinesia-improvement-dyskinesia” pattern of levodopa responses, or severe wearing-off dystonia will be excluded.
- •- Patients characterized as Hoehn & Yahr Stages >4, without clinical features of dementia, freezing” of gait, or other significant neurological abnormalities.
- •- Positive test for HIV and Hepatitis A, B, and C
- •- Positive urine drug screen or positive alcohol breathalyzer test.
- •- Insufficiently controlled hypertension (blood pressure > 160/100)
- •- Atrial fibrillation, atrial- nodal- or ventricular arrhythmia, ventricular tachyarrhythmia
- •- History of gastrointestinal surgery or gastrointestinal disease which could affect drug absorption or elimination.
- •- Presence of clinically significant urinary tract obstruction
- •- Patients who donated more than 450 mL of blood within 30 days of the administration of study medication
- •- Patients who have co-morbid neurological or psychiatric disorders (even if they don’t require medications).
- •- Subjects who are taking medications outlined in Section 9.6.
- •- Disruptive non-compliance with requirements of the study causing an inability to collect valid and reliable data.
- •- History of alcohol abuse or drug abuse.
- •- Smokers of more than 10 cigarettes per day (average of 10 weeks prior to the Screening Visit).
- •- Patients who have ingested or who have been administered an investigational compound within 30 days prior to first study medication in this study.
- •- Any condition the clinical investigator deems to be a significant risk to the patient or the scientific integrity of the study.
研究者
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