Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life (OPTIDOM)

Care for Parkinson's patients at the end of life is far from optimal, particularly due to specificities linked to the disease itself, often unknown to non-specialists.

A study carried out at the CHU Rennes on data covering the period 2006-2018 showed that only 132 patients died in this hospital, two-thirds of whom came from home. In 42% of cases, antiparkinsonian treatment was stopped before death without specialist advice (palliative or neurological), with the corollary of the appearance of a dopaminergic withdrawal syndrome (or pseudo-neuroleptic malignant syndrome) in a high proportion of these patients. Neuroleptic pseudo-malignant syndrome is a major cause of discomfort. If left untreated, it can precipitate death in particularly distressing conditions for the patient, his or her family and caregivers.

The Rennes study also suggests that Parkinson's patients rarely die in hospital. In fact, work carried out by FNEHAD on data for 2022 showed that 1,800 Parkinson's patients were cared for in HAH in France during that same year, mainly for palliative care or heavy nursing reasons. Half of these patients died.

End-of-life management of Parkinson's disease therefore requires local clinical and pharmacological expertise. A recent observational study suggests that the use of a subcutaneous apomorphine pump brings substantial benefits in terms of clinical comfort, both motor and non-motor, as well as relief for family and friends, easier nursing care for the nursing team, and in some cases, renewed communication.

Such care can be provided in the home, and must necessarily be multidisciplinary, combining palliative expertise, provided by Home Hospitalization (HH) teams, with technical and Parkinson's expertise, provided by Home Healthcare Providers (HHPs) experienced in managing the apomorphine pump, in liaison with the referral team.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Marc VERIN, MD PhD; Phone Number: 02 38 51 48 86; Email: marc.verin@chu-orleans.fr

Study Locations

• France
  • Crest, France
    • Recruiting
    • Had Crest
    • Contact: GIRARD TAOS, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Parkinsonian patients treated in HH.

Description

Inclusion Criteria:

1. Person (or trusted person/relative if patient is unable) who has agreed to participate in the study
2. Patient of legal age
3. Advanced Parkinson's disease with apomorphine pump indication
4. Use of HH for palliative reasons
5. Loss of orality (discontinuation of oral treatments)
6. Hoehn &Yahr score in OFF = 5 (bilateral and axial symptoms in the absence of levodopa)

Exclusion Criteria:

1. Apomorphine pump already in use
2. Opposition to the introduction of an apomorphine pump
3. Protected person (under guardianship or curatorship)
4. Person under court protection
5. Persons deprived of liberty
6. Persons not affiliated to a social security scheme
7. Pregnant or breast-feeding woman

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson patients; Parkinsonian patients in HH will receive an apomorphine pump as part of their routine care. Questionnaires will be completed at D0, D2, D4, D6, D12, D18, D24, D30 and D45. The questionnaires used will be; UPDSR III: rigidity; Algoplus; Richmond Scale (RASS); Likert scale Entourage before/after; Likert scale Caregivers before/after; Zarit scale	Other: Questionnaires; Parkinsonian patients in HH will receive an apomorphine pump as part of their routine care. Questionnaires will be completed at D0, D2, D4, D6, D12, D18, D24, D30 and D45. The questionnaires used will be; UPDSR III: stiffness; Algoplus; Richmond Scale (RASS); Likert scale Entourage before/after; Likert scale Caregivers before/after; Zarit scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rigidity	measured by the specific sub-section of rigidity of the internationally recognized UPDRS 3 scale validated in French. This criterion will be assessed before the apomorphine pump is installed and 6 days afterwards. The 5 items are scored from 0 to 4, so the total score ranges from 0 to 20.	Day 0
Rigidity	measured by the specific sub-section of rigidity of the internationally recognized UPDRS 3 scale validated in French. This criterion will be assessed before the apomorphine pump is installed and 6 days afterwards. The 5 items are scored from 0 to 4, so the total score ranges from 0 to 20.	Day 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in analgesic consumption	Change in analgesic consumption will be recorded at Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45 and will be evaluated at the end of the study	Day 45
Change in alertness and agitation levels	It will be will be evaluated by the Richmond Scale, from + 4 to -4 with +4 for very combative patient and -4 for unresponsive patient.	Day 45
Change in communication with the care team and relatives	It will be evaluated with the Lickert scale for care team that assesses the patient's communication ability from -3 to +3 with -3 for greatly aggravated and +3 for greatly improved	Day 45
Change in nursing care	It will be evaluated with the Lickert scale for caregivers that assesses the level of quality of nursing care. from -3 to +3 with -3 for greatly aggravated and +3 for greatly improved	Day 45
Change in caregiver burden	It will be evaluated with Zarit scale . The total score is the sum of the scores obtained for each of the 22 items, ranging from 0 to 88. A score of 20 or less indicates a low or no burden; a score between 21 and 40 indicates a mild burden; a score between 41 and 60 indicates a moderate burden; a score above 60 indicates a severe burden.	Day 0, 2, 6, 18, 30 and Day 45
Proportion of nausea/vomiting		Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hypotension		Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of skin condition related to apomorphine		Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hallucinations		Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Collaborators: Fédération Francaise d'Hospitalisation à Domicile (FNEHAD); France Développement Electronique (FDE)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 18, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson; Apomorphine; End of life
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Pathological Conditions, Signs and Symptoms; Parkinson Disease; Death; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: CHUO-2025-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No