EUCTR2007-000074-23-IT进行中（未招募）不适用
A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND
BOEHRINGER ING.0 个研究点目标入组 645 人开始时间: 2007年4月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 645
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
- •Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time. Patients must be treated with L-Dopa i.e. standard and/or controlled release Levodopa/DDC inhibitor , or with a combination of L-Dopa and entacapone, at an optimized dose according to investigator s judgement, this dose being stable for at least 4 weeks prior to baseline. They must have motor fluctuations at least 2 cumulative hours of off-time every day during waking hours, documented on a patient diary completed for 2 consecutive days before baseline visit . Patients must not have been treated with dopamine agonists within 4 weeks prior to baseline. A concomitant treatment with one or more of the following drugs will be allowed at a stable dose for at least 4 weeks prior to baseline and the investigator does not intent to change this treatment during the treatment phase - anti-parkinsonian anticholinergics; - selegiline, rasagiline, or other MAO-B-Inhibitor; - amantadine; - entacapone or other COMT-Inhibitor ; - beta-blockers e.g. propranolol when used to treat PD. A previous treatment with pramipexole IR will be allowed, provided the treatment was not discontinued due to a serious/clinically significant drug related adverse event, according to investigator s judgement.
- •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
- •-Atypical parkinsonian syndromes due to drugs e.g., metoclopramide, flunarizine , metabolic disorders e.g., Wilson s disease , encephalitis or degenerative diseases e.g., progressive supranuclear palsy . -Dementia, as defined by a Mini-Mental State Exam score 24 at screening visit. -Any psychiatric disorder according to DSM-IV Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria that could prevent compliance or completion of the study and/or put the patient at risk if he/she takes part in the study. -History of psychosis, except history of drug induced hallucinations provided the investigator considers that participation to the trial would not represent a significant risk for the patient . -History of deep brain stimulation. -Clinically significant electrocardiogram ECG abnormalities at screening visit, according to investigator s judgement. -Clinically significant hypotension i.e. supine systolic blood pressure 90 mmHg and/or symptomatic orthostatic hypotension i.e. clinical symptoms of orthostatic hypotension associated with a decline 20 mmHg in systolic blood pressure and a decline 10 mmHg in diastolic blood pressure, at one minute after standing compared with the previous supine systolic and diastolic blood pressure obtained after 5 minutes of quiet rest at screening or baseline visit. -Malignant melanoma or history of previously treated malignant melanoma. -Any other clinically significant disease, whether treated or not, that could put the patient at risk or could prevent compliance or completion of the study. -Pregnancy to be excluded by serum pregnancy test at screening visit or breast-feeding. -Sexually active female of childbearing potential less than 6 months post-menopausal and not surgically sterilised not using a medically approved method of birth control i.e. oral contraceptives, intrauterine device, or double-barrier for at least one month prior to the screening visit and throughout the study period up to the follow-up visit . -Serum levels of AST SGOT , ALT SGPT , alkaline phosphatases or bilirubin 2 ULN on screening lab test . -Patients with a creatinine clearance 50 mL/min estimated by the Cockcroft and Gault formula and calculated by the central lab on screening lab test . -Any medication including intra-muscular formulations with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc . -Any of the following drugs within 4 weeks prior to baseline visit methylphenidate, cinnarizine, amphetamines. -Flunarizine within 3 months prior to baseline visit. -Known hypersensitivity to pramipexole or its excipients. -Drug abuse including alcohol , according to investigator s judgement, within 2 years prior to screening. -Participation in other investigational drug studies, or use of other investigational drugs within one month or five times the half-life of the investigational drug whichever is longer prior to baseline visit.
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