NCT00321854已完成4 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 535
- 试验地点
- 99
- 主要终点
- Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
研究概览
简要总结
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;
- •Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);
- •Parkinsons disease newly diagnosed within the past 2 years;
- •Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);
- •Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Previous history of allergic response or complications with pramipexole (PPX) or its excipients;
- •Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);
- •The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;
- •The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;
- •If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;
- •The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;
- •The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;
- •The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);
- •History of stereotactic brain surgery;
- •Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;
- •History of active epilepsy (i.e., occurrence of a seizure) within the past year;
- •Symptomatic orthostatic hypotension prior to randomization;
- •Malignant melanoma or history of previously treated malignant melanoma;
- •Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;
- •Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);
- •Patients who are currently pregnant or planning pregnancy during the study, or lactating;
- •Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;
- •History of psychosis;
- •A diagnosis of dementia
研究组 & 干预措施
Early Pramipexole
Experimental
Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
干预措施: pramipexole (Drug)
Delayed Pramipexole
Experimental
Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
干预措施: pramipexole (Drug)
结局指标
主要结局
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
时间窗: Baseline and Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
次要结局
- Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6(Baseline and Month 6)
- Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3(Baseline and Month 3)
- Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6(Baseline and Month 6)
- Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3(Baseline and Month 3)
- Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6(Baseline and Month 6)
- Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3(Baseline and Month 3)
- Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6(Baseline and Month 6)
- Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3(Baseline and Month 3)
- Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6(Baseline and Month 6)
- Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes(Baseline and Month 15)
- Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3(Baseline and Month 3)
- Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15(Month 15)
- Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15(Baseline and Month 15)
- Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9(Baseline and Month 9)
- Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6(Baseline and Month 6)
- Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3(Baseline and Month 3)
- Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15(Baseline and Month 15)
- Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9(Baseline and Month 9)
- Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15(Baseline and Month 15)
- Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9(Baseline and Month 9)
- Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes(Baseline and Month 15)
- Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15(Baseline and Month 15)
- Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9(Baseline and Month 9)
- Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6(Month 6)
- Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1(Month 1)
- Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9(Month 9)
- Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12(Month 12)
- Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15(Month 15)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1(Month 1)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6(Month 6)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9(Month 9)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12(Month 12)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15(Month 15)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1(Month 1)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6(Month 6)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9(Month 9)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12(Month 12)
- Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15(Month 15)
- Percentage Change From Baseline in the Striatum Uptake at Month 15(Baseline and Month 15)
- Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates(Baseline and Month 15)
- Clinically Significant Abnormalities in Vital Signs(Baseline and Month 15)
研究者
研究点 (99)
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