Parkinson DiseaseOPTIDOMNCT07257861
Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life
An observational study of Parkinson Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Questionnaires
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinsonian patients treated in HH.
Who may be able to join
- Person (or trusted person/relative if patient is unable) who has agreed to participate in the study
- Patient of legal age
- Advanced Parkinson's disease with apomorphine pump indication
- Use of HH for palliative reasons
- Loss of orality (discontinuation of oral treatments)
- Hoehn \&Yahr score in OFF = 5 (bilateral and axial symptoms in the absence of levodopa)
Who cannot join
- Apomorphine pump already in use
- Opposition to the introduction of an apomorphine pump
- Protected person (under guardianship or curatorship)
- Person under court protection
- Persons deprived of liberty
- Persons not affiliated to a social security scheme
- Pregnant or breast-feeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Parkinson Disease
- Being tested
- Questionnaires
- Keywords
- Apomorphine, Parkinson, End of life
- Medical subject headings
- Parkinson Disease, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 6
Secondary outcomes (9)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 0, 2, 6, 18, 30 and Day 45
Proportion of nausea/vomiting
Measured: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hypotension
Measured: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of skin condition related to apomorphine
Measured: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hallucinations
Measured: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start2 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Collaborators
- Fédération Francaise d'Hospitalisation à Domicile (FNEHAD), France Développement Electronique (FDE)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257861
- Sponsor's protocol ID
- CHUO-2025-02
- Acronym
- OPTIDOM
- Status last verified
- Mar 2026
- First submitted
- 18 Sep 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Continuous Subcutaneous Apomorphine in Parkinsonian Patients at the End of Life
- ClinicalTrials.gov ID
- NCT07257861
- Acronym / sponsor ID
- OPTIDOM / CHUO-2025-02
- Conditions
- Parkinson Disease
- Keywords
- Apomorphine, Parkinson, End of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Collaborators
- Fédération Francaise d'Hospitalisation à Domicile (FNEHAD), France Développement Electronique (FDE)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson patients | – | Other: QuestionnairesParkinsonian 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinsonian patients treated in HH.
Key inclusion criteria (6 listed)
- Person (or trusted person/relative if patient is unable) who has agreed to participate in the study
- Patient of legal age
- Advanced Parkinson's disease with apomorphine pump indication
- Use of HH for palliative reasons
- Loss of orality (discontinuation of oral treatments)
Key exclusion criteria (7 listed)
- Apomorphine pump already in use
- Opposition to the introduction of an apomorphine pump
- Protected person (under guardianship or curatorship)
- Person under court protection
- Persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesParkinsonian 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 | Other | Parkinson patients |
Primary outcome
Rigidity
Time frame: Day 0
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.
Rigidity
Time frame: Day 6
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.
9 secondary outcomes
Change in analgesic consumption
Time frame: Day 45
Change in alertness and agitation levels
Time frame: Day 45
Change in communication with the care team and relatives
Time frame: Day 45
Change in nursing care
Time frame: Day 45
Change in caregiver burden
Time frame: Day 0, 2, 6, 18, 30 and Day 45
Proportion of nausea/vomiting
Time frame: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hypotension
Time frame: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of skin condition related to apomorphine
Time frame: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Proportion of hallucinations
Time frame: Day 0, 2, 4, 6, 12, 18, 24, 30 and Day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc VERIN, MD PhD (02 38 51 48 86, marc.verin@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rigidity (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.