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

NCT ID: NCT03693872

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-15
• Study Completion Date: 2022-06-02

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Apomorphine

Withdrawal of dopaminergic agonists at pump initiation

Group Type: OTHER

Apomorphine

Intervention Type: 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

Dopaminergic Agonist + Apomorphine

Continuation of dopaminergic agonists at pump initiation

Group Type: OTHER

Dopaminergic Agonist + Apomorphine

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

APO; AGAPO

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc VERIN, PH

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Hôpital Gui de Chauliac

Montpellier, , France

CH Caremeau

Nîmes, , France

CHU La Pitié Salpêtrière

Paris, , France

CHU de Reims- hôpital Maison Blanche

Reims, , France

CHU de Rennes

Rennes, , France

CHU Charles Nicolle

Rouen, , France

Countries

France

Other Identifiers

35RC18_9721_AGAPO

Identifier Type: -

Identifier Source: org_study_id