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

NCT03693872 | Completed

• 1 other identifier: 35RC18_9721_AGAPO
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

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).

Conditions

Parkinson Disease

Keywords

Parkinson; Nonmotor symptomatology

Outcome Measures

Primary Outcomes (1)

• Difference in the Non Motor Symptoms Scale (NMSS) between the Baseline assessment and the assessment at 6 months' follow up

  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).

  6 months

Secondary Outcomes (17)

• 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 the Neurologist Global Impression of change (CGI) 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 occurrence of anxiety (STAI-YA) between the Baseline assessment and the assessment at 6 months' follow up

  6 months

Study Arms (2)

Apomorphine

OTHER

Withdrawal of dopaminergic agonists at pump initiation

Drug: Apomorphine

Dopaminergic Agonist + Apomorphine

OTHER

Continuation of dopaminergic agonists at pump initiation

Drug: Dopaminergic Agonist + Apomorphine

Interventions

Apomorphine DRUG

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

Also known as: APO

Apomorphine

Dopaminergic Agonist + Apomorphine DRUG

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

Also known as: AGAPO

Dopaminergic Agonist + Apomorphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (6)

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

CH Caremeau

Nîmes, 30029, France

Location

CHU La Pitié Salpêtrière

Paris, 75013, France

Location

CHU de Reims- hôpital Maison Blanche

Reims, 51100, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine; Dopamine Agonists

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Marc VERIN, PH

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: open
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional to minimal risks and constraints, non randomized, open

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: May 15, 2019
• Primary Completion: June 2, 2022
• Study Completion: June 2, 2022
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)