EUCTR2007-000073-39-FI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 patients with early Parkinson's disease (PD)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 patient with idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •Parkinson’s disease diagnosed within 5 years.
- •Patients 30 years of age or older at the time of diagnosis.
- •Modified Hoehn and Yahr stage of 1 to 3.
- •Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrolment according to the investigator’s judgement.
- •Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- •Signed informed consent obtained before any study procedures are carried out
- •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 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 in the trial would not represent a significant risk for the patient).
- •Clinically significant electrocardiogram 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) either at screening visit or at 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 sterilized) 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 dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit, or L-Dopa within 8 weeks prior to baseline visit.
- •Total cumulative duration of prior exposure to Levodopa of more than 3 months.
- •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 the 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.
研究者
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