NCT00466167已完成3 期
A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 76
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
研究概览
简要总结
The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations.
In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done.
The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 32 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient with advanced idiopathic Parkinsons disease confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •Parkinsons 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 Levodopa combined with a Dopa-Decarboxylase-inhibitor, or with Levodopa combined with a Dopa-Decarboxylase-inhibitor/entacapone, at an optimised dose according to investigators 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 International Conference on Harmonisation-Good Clinical Practice guidelines and local legislation).
排除标准
- •Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases
- •Dementia, as defined by a Mini-Mental State Exam score < 24 at screening visit
- •Any psychiatric disorder according to 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
- •History of deep brain stimulation
- •Clinically significant Electrocardiogram abnormalities at screening visit
- •Clinically significant hypotension and/or symptomatic orthostatic hypotension 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 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 screening visit and throughout the study period
- •Serum levels of Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase), Alanine Aminotransferase (Serum Glutamic Pyruvic Transaminase), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal
- •Patients with a creatinine clearance < 50 millilitres/minute
- •Any dopamine agonist (including pramipexole) within 4 weeks prior to baseline visit
- •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 visit
- •Known hypersensitivity to pramipexole or its excipients
- •Drug abuse according to investigators 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
研究组 & 干预措施
Pramipexole ER
Other
干预措施: Pramipexol Extended Release (Drug)
Pramipexole IR
Other
干预措施: Pramipexol Immediate Release (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Score at Week 18
时间窗: baseline and week 18
UPDRS II+III total score on Full Analysis Set (FAS)with LOCF (Last observation carried forward), week 18 - baseline, UPDRS II+III ranging from 0 (normal) to 160 (severe). UPDRS part II measures activities of daily living, part III measures motor symptoms
次要结局
- Change From Baseline in Percentage Off-time at Week 18(baseline and week 18)
- Change From Baseline in Percentage On-time Without Dyskinesia at Week 18(baseline and week 18)
- Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18(baseline and week 18)
- Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18(baseline and week 18)
- Clinical Global Impression - Global Improvement (CGI-I) Responder(after 18 weeks of treatment)
- Response in Patient Global Impression (PGI-I)(after 18 weeks of treatment)
- Change From Baseline in UPDRS I Score After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in UPDRS II Score After 18 Weeks, Average at on and Off-period(baseline and 18 weeks)
- Change From Baseline in UPDRS III Score After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in UPDRS IV Score After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in Beck's Depression Inventory (BDI) After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in Parkinson's Disease Quality of Life Questionnaire 39 After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in European Quality of Life (EuroQol) Scale After 18 Weeks(baseline and 18 weeks)
- Change From Baseline in 11-point Likert Scale for Pain Related to PD at Week 18(baseline and week 18)
- Clinically Significant Abnormalities: Clinical Laboratory Evaluations (Biochemistry and Haematology)(baseline and week 18)
研究者
研究点 (76)
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