NCT07257861 Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life
| NCT ID | NCT07257861 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Régional d'Orléans |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-02-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07257861 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07257861 currently recruiting?
Yes, NCT07257861 is actively recruiting participants. Contact the research team at marc.verin@chu-orleans.fr for enrollment information.
Where is the NCT07257861 trial being conducted?
This trial is being conducted at Crest, France.
Who is sponsoring the NCT07257861 clinical trial?
NCT07257861 is sponsored by Centre Hospitalier Régional d'Orléans. The trial plans to enroll 80 participants.
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