A Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 58
- 主要终点
- Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III
研究概览
简要总结
To assess the efficacy of rasagiline 1 mg as a first add-on treatment to dopamine agonist therapy in early Parkinson Disease (PD) patients, , not optimally controlled on dopamine agonists as compared to placebo.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •receiving stable dose of oral ropinirole or pramipexole whose symptoms are not optimally controlled or whose oral dopamine agonist titration regimen was truncated due to intolerability:
- •Minimum dose of agonist will be 6 mg/day for ropinirole and 1.0 mg/day for pramipexole
- •Stable dopamine agonist treatment must have been ongoing for ≥ 30 days, no longer than 5 years preceding baseline
- •Males and females. Women of childbearing potential must agree to practice an acceptable method of birth control.
- •Idiopathic Parkinson Disease confirmed at baseline by presence of at least 2 cardinal signs (resting tremor, bradykinesia, rigidity), w/o other known or suspected cause of Parkinsonism
- •Hoehn & Yahr > 1 (symptoms on only one side of the body) with treatment and < 3 (mild to moderate bilateral disease; some postural instability; physically independent).
- •Dopamine agonist dose must be stable for ≥30 days preceding the baseline visit.
- •For patients who are receiving amantadine or anticholinergics, the dose must have been stable for ≥30 days prior to screening.
- •Medically stable outpatients (Investigator's judgment).
排除标准
- •receive rasagiline or other monoamine oxidase (MAO) inhibitors 60 days preceding baseline
- •receive levodopa > 21 consecutive days within 90 days prior baseline
- •moderate to severe motor fluctuations
- •hepatic impairment
- •investigational medications 30 days preceding baseline
- •dopamine agonist use > 5 years prior to baseline
- •major depression as defined by Beck Depression Inventory (BDI) short form score greater than 14
- •significant cognitive impairment as defined by Mini-Mental State Exam (MMSE) score less than
- •impulse control disorder (ICD) based on the Questionnaire for Impulsive-compulsive Disorders in Parkinson's Disease form (QUIP).
- •pregnant or lactating or planning on becoming pregnant in the next 18 weeks
- •uncontrolled hypertension. Patients whose hypertension is controlled with medications are eligible.
- •Concomitant monoamine oxidase (MAO) inhibitors or medicines contraindicated w/ MAO inhibitors not allowed
研究组 & 干预措施
Rasagiline 1 mg
Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
干预措施: Rasagiline (Drug)
Placebo
Participants took a matching placebo tablet once daily for 18 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Parts I, II and III
时间窗: Day 0 (baseline), Week 18
The UPDRS was developed as a comprehensive tool to monitor the impact of Parkinson's Disease and the degree of disability caused. Version 3 of UPDRS contains four parts, three of which are totaled and reported in this outcome. Part I is a clinician's evaluation of mentation (mental activity or state of mind), cognition (ability to acquire knowledge), behaviour and mood. Part II is the participants' evaluation of the disease's impact on normal activities. Part III is a clinician's evaluation of motor function. Parts I, II, and III contain a total of 31 questions, which are each rated on a scale of 0 (normal or no disease effect) to 4 (maximum negative effect), for a total scale of 0-124. Negative change from baseline values indicate improvement. All site raters (medical doctor \[MD\], doctor of osteopathy \[DO\], nurse practitioner, or physician assistant) received training on how to complete the UPDRS. The same site rater completed the UPDRS at all visits.
次要结局
- Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part II - Activities of Daily Living(Day 0 (baseline), Week 18)
- Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Participant(18 weeks)
- Change From Baseline to Week 18 in the Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Part III - Motor Function(Day 0 (baseline), Week 18)
- Illness Severity Score at Day 0 and Week 18 As Assessed by the Site Rater(Day 0 (baseline), Week 18)
- Clinical Global Improvement (CGI) Score at Week 18 As Assessed by the Site Rater(18 weeks)