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

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Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

May 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Interventional to minimal risks and constraints, non randomized, open
Masking: Interventional
Masking Description:open
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Other: Apomorphine
Withdrawal of dopaminergic agonists at pump initiation
Other: Dopaminergic Agonist + Apomorphine
Continuation of dopaminergic agonists at pump initiation

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2021

Estimated Primary Completion Date

May 1, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Rennes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Marc VERIN, PH Rennes University Hospital

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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