NCT01683253已完成4 期
The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy
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
- Sandoz
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- mMIDI(modified Minnesota Impulsive Disorders Interview)
研究概览
简要总结
The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated with dopaminergic medications.
详细描述
- PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
- SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's Disease Brain Bank Criteria
- •mMIDI ≥ 3 score with ICD
- •Patients must be on an anti-parkinson treatment at least 6 months before screening.
- •for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment.
- •30years ≤ patients < 80years of age, male or female
- •patients must give written informed consent before any assessment is performed
排除标准
- •Requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future
- •for the patients ≤ 65years: K-MMSE(korean version of Mini-Mental State Exam) ≤24, or for the patients ≥ 66years: K-MMSE ≤ 20, or the patients have dementia(incl. early dementia) even though K-MMSE score is more than 20
- •Requirement of treatment more than 6times per day due to the severe motor fluctuation.
- •Severe dyskinesia
- •DBS(Deep Brain Stimulation)or any other surgical treatment
- •History of melanoma or not-diagnostic skin trouble/skin lesions
- •narrow angle glaucoma
- •clinically serious surgical or medical condition
- •malignant tumor
- •use of other investigational drugs at the time of enrollment within 4weeks
- •pregnant, nursing or lactating women
- •women of child-bearing potential
- •history of hypersensitivity or allergy to levodopa/carbidopa
- •any serious disease according to the investigator's discretion
研究组 & 干预措施
Levodopa/Carbidopa(200mg/50mg)
Experimental
干预措施: Levodopa/Carbidopa(200mg/50mg) (Drug)
Control A (dopaminergic agonist )
Experimental
Parkinson patients treated with anti-Parkinson drug over 6 months.
干预措施: Dopaminergic Agonists (Drug)
结局指标
主要结局
mMIDI(modified Minnesota Impulsive Disorders Interview)
时间窗: 12weeks
To evaluate the improvement of mMIDI(Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)
次要结局
- Neuropsychiatric profile(12 weeks)
研究者
研究点 (1)
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