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

Rennes University Hospital

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Apomorphine; Drug: Dopaminergic Agonist + Apomorphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03693872

35RC18_9721_AGAPO

Details and patient eligibility

About

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).

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Apomorphine

Other group

Description:

Withdrawal of dopaminergic agonists at pump initiation

Treatment:

Drug: Apomorphine

Dopaminergic Agonist + Apomorphine

Other group

Description:

Continuation of dopaminergic agonists at pump initiation

Treatment:

Drug: Dopaminergic Agonist + Apomorphine