NCT00391898已完成4 期
A 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With Levodopa
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 95
- 试验地点
- 26
- 主要终点
- Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
研究概览
简要总结
The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ages ≥ 30 and ≤ 80 years old.
- •A clinical diagnosis of idiopathic Parkinson's disease.
- •Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
- •Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.
- •1 full tablet, and/or
- •1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
- •Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
- •Must have a minimum UPDRS part II (ADL) score of
- •Patients without dyskinesia or with mild dyskinesia.
- •Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
- •Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.
排除标准
- •Previous or current use of entacapone.
- •History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
- •Unstable Parkinson's disease patients.
- •Patients who experience severe dyskinesia.
- •The following levodopa/carbidopa doses and strengths are not permitted:
- •Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
- •Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
- •Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
- •Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
- •Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
- •Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
- •Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
- •Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
- •Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
研究组 & 干预措施
Levodopa/carbidopa/entacapone
Experimental
干预措施: Levodopa/carbidopa/entacapone (Drug)
Levodopa/carbidopa
Active Comparator
干预措施: Levodopa/carbidopa (Drug)
结局指标
主要结局
Change in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living [ADL]) Score From Baseline to Month 3
时间窗: Baseline to end of study (Month 3)
The UPDRS is a standardized assessment scale used to measure a patient's disease state. It is completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52, calculated as the sum of the individual items) measures the patient's activities of daily living. A lower total score indicates greater symptom control. A negative change score indicates improvement.
次要结局
- Change in the UPDRS Part IV (Complications of Therapy) Score From Baseline to Month 3(Baseline to end of study (Month 3))
- Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) Total Score From Baseline to Month 3(Baseline to end of study (Month 3))
- Change in the UPDRS Part I (Mentation, Behavior, and Mood) Score From Baseline to Month 3(Baseline to end of study (Month 3))
- Change in the UPDRS Part III (Motor Function) Score From Baseline to Month 3(Baseline to end of study (Month 3))
- Change on the QUICK Questionnaire (QQ) Score From Baseline to Month 3(Baseline to end of study (Month 3))
- Patient and Investigator Global Evaluation of the Patient(Baseline to end of study (Month 3))
研究者
研究点 (26)
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