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Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

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合作者:
信息的提供 (责任方):
October 1, 2018
October 3, 2018
October 3, 2018
November 1, 2018
May 1, 2021   (主要结果测量的最终数据收集日期)
Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
Scale to evaluate non motor symptoms such as cardiovascular, sleep / fatigue, mood / apathy, hallucinations, attention / memory, gastrointestinal, urinary, sexual symptoms

与当前相同
  • Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
    Scale to evaluate the Quality of life
  • Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
    Scale to evaluate the Quality of life
  • 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[ Time Frame: 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)[ Time Frame: 6 months ]
  • Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
    Present feelings
  • Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
    General feelings
  • Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 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[ Time Frame: 6 months ]
    Trait Emotional Intelligence Questionnaire (TEIQue )
  • 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[ Time Frame: 6 months ]
    Berkeley's Expressivity Questionnaire (BEQ)
  • 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[ Time Frame: 6 months ]
  • Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
  • Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
  • Change in motor examination with the Schwab and England scale between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
  • Change in motor examination with the Hoehn & Yarr scale[ Time Frame: 6 months ]
  • Change in cognitive function assessed by the MoCA scale between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
    Montreal Cognitive Assessment (MoCA)
  • Change of dose for treatments assessed by levodopa (L-DOPA) équivalents between the Baseline assessment and the assessment at 6 months' follow up[ Time Frame: 6 months ]
  • Frequency, type and severity of therapy-related adverse events[ Time Frame: 6 months ]
 
Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals

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).

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.
Interventional
N/A
分配: Non-Randomized
干预模型: Parallel Assignment
干预模型描述: Interventional to minimal risks and constraints, non randomized, open
盲法: Interventional
盲法描述:open
主要目的: Other
  • Drug: Apomorphine
    Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient
  • Drug: Dopaminergic Agonist + Apomorphine
    Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient and associated with dopaminergic agonists
  • Other: Apomorphine
    Withdrawal of dopaminergic agonists at pump initiation
  • Other: Dopaminergic Agonist + Apomorphine
    Continuation of dopaminergic agonists at pump initiation
 
Not yet recruiting
42
与当前相同
September 1, 2021
May 1, 2021   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - 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 Exclusion Criteria: - 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.
参与研究的性别: All
最小年龄:18 Years ,最大年龄:N/A  
没有
France
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No
计划分享 IPD: No
Rennes University Hospital
Principal Investigator: Marc VERIN, PH Rennes University Hospital
October 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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