EUCTR2007-004235-37-HU进行中（未招募）1 期
ong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD
Boehringer Ingelheim Pharma Ges mbH0 个研究点目标入组 390 人开始时间: 2008年1月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 390
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
- •Completion of the double-blind trial 248.525
- •Male or female patient with advanced idiopathic Parkinson’s disease (PD), with a Modified Hoehn and Yahr stage of 2 to 4 at on-time, and a concomitant treatment with standard or controlled release L-Dopa+, or a combination of L-Dopa+ and entacapone.
- •Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular the patient should be able to recognise the offtime and on-time periods during waking hours and the patient (or a family member or a guardian) should be able to record them accurately in the patient diary.
- •Signed informed consent obtained before any study procedures are carried out (in
- •accordance with ICH-GCP guidelines and local legislation).
- •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
- •Patients prematurely withdrawn from the double-blind trial 248.525, will not be allowed to enter the open-label extension study
- •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)
- •Any psychiatric disorder according to DSM-IV 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 baseline according to investigator’s judgement
- •Clinically significant hypotension and/or symptomatic orthostatic hypotension at baseline
- •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 or breast-feeding
- •Sexually active female of childbearing potential not using a medically approved method of birth control for at least one month prior to the baseline and throughout the study
- •Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatases or bilirubin > 2 ULN at baseline
- •Patients with a creatinine clearance < 50 mL/min at baseline
- •Any medication with central dopaminergic
- •antagonist activity within 4 weeks prior to the baseline visit
- •Any of the following drugs within 4 weeks prior to baseline visit: methylphenidate,
- •cinnarizine, amphetamines
- •Flunarizine within 3 months prior to baseline
- •Known hypersensitivity to pramipexole or its excipients.
- •Drug abuse, according to investigator’s judgement, within 2 years prior to baseline
- •Participation in investigational drug studies other than the trial 248.525, 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
研究者
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