Clinical trial NCT03693872: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
Official title: Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Nonmotor symptomatology
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional to minimal risks and constraints, non randomized, open
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
Secondary outcomes:
measure: Change in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in the Neurologist Global Impression of change (CGI) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: Change in occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in occurrence of anxiety (STAI-YB) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in behavioral symptoms assessed by Ardouin Scale between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in emotional function assessed by the short form of the TEIQue between the Baseline assessment and the assessment at 6 months' follow upscale
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Change in motor examination during "on" periods (MDS-UPDRS III) between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in motor complications with MDS-UPDRS IV between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in motor examination with the Schwab and England scale between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change in motor examination with the Hoehn & Yarr scale
timeFrame: 6 months
measure: Change in cognitive function assessed by the MoCA scale between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Change of dose for treatments assessed by levodopa (L-DOPA) équivalents between the Baseline assessment and the assessment at 6 months' follow up
timeFrame: 6 months
measure: Frequency, type and severity of therapy-related adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Nîmes
country: France
facility: CH Caremeau
city: Paris
country: France
facility: CHU La Pitié Salpêtrière
city: Reims
country: France
facility: CHU de Reims- hôpital Maison Blanche
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Charles Nicolle
Study officials:
affiliation: Rennes University Hospital
name: Marc VERIN, PH
role: PRINCIPAL_INVESTIGATOR
References: