NCT00479401
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 ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).
概览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 539
- 试验地点
- 95
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score
概览
简要总结
The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole.
In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 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 idiopathic Parkinsons disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
- •Parkinsons 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
- •Patients requiring additional therapy/ introduction of therapy (for de novo patients) to treat their parkinsonian symptoms at the time of enrollment (screening visit, V1) according to the investigators judgement.
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 Diagnostic and Statistical Manual of Mental Disorders 4th (DSM-IV)
- •History of psychosis
- •Clinically significant electrocardiogram (ECG) abnormalities at screening visit
- •Clinically significant hypotension
- •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
- •Sexually active female of childbearing potential not using a medically approved method of birth control
- •Serum levels of Aspartate Aminotransferase (AST) , Alanine Aminotransferase (ALT), alkaline phosphatases or bilirubin \> 2 Upper Limit of Normal (ULN)
研究组 & 干预措施
Pramipexole Extended Release (PPX ER)
Experimental
干预措施: Pramipexol Extended Release (Drug)
Pramipexole Immediate Release (PPX IR)
Experimental
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 Total Score
时间窗: baseline and after 33 weeks treatment
Activities of daily living are scored from 0-52 in UPDRS II, result of motor examination scored 0-108 in UPDRS III. A decrease in the score means improvement.
次要结局
- Percentage of Responders on the Clinical Global Impressions of Improvement (CGI-I) Scale(after 18 weeks of treatment compared to baseline)
- UPDRS II+III Responder Rate (at Least 20% Improvement)(after 33 weeks treatment)
- Parkinson's Disease Sleep Scale (PDSS)(after 33 weeks treatment)
- Change From Baseline in Parkinson's Disease Quality of Life Questionnaire Total Score(after 33 weeks treatment)
- Patients Who Started to Use L-Dopa Rescue Medication(from trial start on to any time before final assessment of the patient, up to 33 weeks)
- Possible Clinically Significant Abnormal Laboratory Parameters(baseline and after 33 weeks of treatment)
- Percentage of Responders on the Patients Global Impressions of Improvement (PGI-I) Scale(after 18 weeks of treatment compared to baseline)
- UPDRS Part II Total Score(after 33 weeks treatment)
- Likert Scale for Pain Related to PD(after 33 weeks treatment)
- UPDRS Part I Change From Baseline(baseline and after 33 weeks treatment)
- UPDRS Part III Total Score(after 33 weeks treatment)
- Beck's Depression Inventory Version I A(after 33 weeks treatment)
- Number of Patients With Treatment Emergent Abnormal Behaviour as Indicated by the Modified Minnesota Impulsive Disorders Interview (mMIDI Questionnaire)(from trial start on to any time before final assessment of the patient, up to 33 weeks)
- Change From Baseline in European Quality of Life Visual Analog Scale(after 33 weeks treatment)
- Clinical Relevant Abnormal Findings in Vital Signs and Physical Examination as Reported in Adverse Events(baseline and after 33 weeks of treatment)
研究者
研究点 (95)
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