Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 6
- 主要终点
- Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up
研究概览
简要总结
There is currently no consensus on the adequate concomitant treatment to apomorphine pump in Parkinson's disease (PD). In practice, some centers withdraw all dopaminergic agonists when initiating apomorphine pump therapy, whereas others combine the two. To date, there has been no study led to determine the best strategy for efficiently treating motor and nonmotor symptoms, as well as improving patients' quality of life (QoL). This preliminary study, entitled AGAPO, aims at identifying significant differences in patients' evolution (nonmotor symptoms and quality of life), over a course of 6 months, depending on the two strategies adopted in French centers (apomorphine pump with or without dopaminergic agonists), through the Non Motor Symptoms Scale (NMSS, Chaudhuri et al, 2017).
详细描述
The recruitment period will be 24 months. The duration of the study will be 6 months for each patient due to adjustments of apomorphine pump parameters and oral medication as well time needed for motor and nonmotor changes to develop and influence QoL.
This study will be done without any modification of the planned treatment plan for each patient included. The treatments are administered in accordance with their marketing authorization and according to the usual practices of each center. No additional visits are expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
open
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged = or > 18 years,
- •Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of symptoms,
- •Indicated for apomorphine pump therapy and according to the centers' practice, treatment with apomorphine pump association with dopamine agonists or apomorphine pump therapy alone
- •Presence of fluctuations for > 3 years,
- •Patients covered with social insurance.
- •Written informed consent
排除标准
- •Neurological (other than Parkinson's disease) or severe psychiatric history (depression, schizophrenia, addiction, bipolar disorder, anxiety and depressive disorders);
- •Severe neurocognitive disorders (DSM-V)
- •History of use of apomorphine pump treatment or deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa;
- •History or current drug or alcohol abuse or dependencies;
- •History of impulse control disorders;
- •Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty;
- •Inability to understand the information given on the study, to express informed consent.
研究组 & 干预措施
Apomorphine
Withdrawal of dopaminergic agonists at pump initiation
干预措施: Apomorphine (Drug)
Dopaminergic Agonist + Apomorphine
Continuation of dopaminergic agonists at pump initiation
干预措施: Dopaminergic Agonist + Apomorphine (Drug)
结局指标
主要结局
Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up
时间窗: 6 months
The Non-Motor Symptoms Scale (NMSS) measures the frequency and severity of a range of non-motor symptoms in Parkinson's Disease, through 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous (pain, taste/smell, weight change, excessive sweating). Severity is rated on a scale from 0 (none) to 3 (severe). Frequency is rated on a scale from 1 (rarely) to 4 (very frequent). Item scores are calculated as the product of severity and frequency; the total score is obtained by summing the item scores. The NMSS total score ranges from 0 to 360 with a lower score indicating fewer symptoms. A negative change from baseline indicates improvement in symptoms (reduced score).
次要结局
- Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in motor examination with the Schwab and England scale between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in emotional function assessed by the short form of the TEIQue between the Baseline assessment and the assessment at 6 months' follow upscale(6 months)
- Change in motor examination with the Hoehn & Yarr scale(6 months)
- Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change of dose for treatments assessed by levodopa (L-DOPA) équivalents between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Frequency, type and severity of therapy-related adverse events(6 months)
- Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in emotional function assessed by the short form of the BEQ scale between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in cognitive function assessed by the MoCA scale between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the Baseline assessment and the assessment at 6 months' follow up(6 months)
- Change in apathy assessed on the long version of Lille Apathy Rating Scale between the Baseline assessment and the assessment at 6 months' follow up (LARS)(6 months)
- Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6 months' follow up(6 months)