EUCTR2007-004234-16-FR进行中（未招募）1 期
ong-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 520
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 trial 248.524 or 248.636.
- •Male or female with early idiopathic Parkinson´s disease and with Modified Hoehn and Yahr stage I-III.
- •Patients willing and able to comply with the study procedures.
- •Signed informed consent.
- •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
- •Premature withdrawal from study 248.524 or 248.636.
- •Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
- •Any psychiatric disorder according to DSM-IV criteria that could prevent compliance or completion of the study and/or put patient at risk if he/she takes part in the study.
- •History of psychosis, except history of drug induced hallucinations.
- •Clinically significant ECG abnormalities.
- •Clinically significant hypotension (i.e. supine 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 baseline.
- •Malignant melanoma or history of previously treated malignant melanoma.
- •Any other clinically significant disease that could put the patient at risk or could prevent compliance or completion of the study.
- •Pregnancy and breast-feeding.
- •Sexually active female of childbearing potential not using medically approved method of birth control.
- •Serum levels of AST (SGOT), ALT (SGPT), alkaline phosphatase or bilirubin > 2 ULN at baseline.
- •Patients with creatinine clearance < 50 mL/min.
- •Motor complications under levodopa therapy (e.g. on-off phenomena, dyskinesia) at baseline.
- •Any medication with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit.
- •Methylphenidate, cinnarizine, amphetamines within 4 weeks prior to baseline.
- •Flunarizine within 3 months prior to baseline.
- •Known hypersensitivity to pramipexole or its excipients.
- •Drug abuse (including alcohol) according to investigator´s judgement, within 2 years prior to baseline.
- •Participation in investigational drug studies, other than 248.524 and 248.636, 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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