EUCTR2007-000074-23-GB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).
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 516
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 advanced idiopathic Parkinson’s disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •Parkinson’s disease diagnosed for at least 2 years.
- •Patients 30 years of age or older at the time of diagnosis.
- •Modified Hoehn and Yahr stage of 2 to 4 at on-time.
- •Treatment with standard or controlled release L-Dopa+, or with L-Dopa+/entacapone, at an optimised dose according to investigator’s judgement, this dose being stable for at least 4 weeks prior to baseline visit.
- •Motor fluctuations, with 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).
- •Patient willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. In particular, after training, it has to be documented at baseline visit that the patient is able to recognise the off-time and on-time periods during waking hours and that the patient (or a family member or a guardian) is 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
- •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 MDRD (Modification of Diet in Renal Disease) formula and calculated by the central lab on screening lab test)
- •Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit.
- •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.
研究者
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