Patients With Parkinson's Disease Treated With Apomorphine PumpsPOLEMICNCT05331573
Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
An observational study of Patients With Parkinson's Disease Treated With Apomorphine Pumps, run by University Hospital, Rouen at 7 sites in France.
Trial summary
Treatment with subcutaneous apomorphine will be initiated according to the usual procedures at each centre. Once the patient is included in the study, he/she will be followed for 24 months according to a schedule of visits corresponding to his/her follow-up care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Parkinson's Disease Treated With Apomorphine Pumps
- What is being tested?
- apomorphine pump
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Oct 2020to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with Parkinson's disease treated with apomorphine pumps
Who may be able to join
- Age greater than or equal to 18 years,
- Diagnosis of Parkinson's disease according to the MDS criteria (2015),
- Patients with a prescription for subcutaneous apomorphine pump therapy,
- Patient having read and understood the information letter and having expressed oral non-opposition to the research.
Who cannot join
- Patient unable to express opposition or non-opposition,
- Patient not affiliated to the social security system,
- Pregnant woman or woman in labour or breastfeeding,
- Person deprived of liberty by an administrative or judicial decision,
- Person placed under court protection, guardianship or curatorship.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
CHU Amien
Amiens
Lydie ROMEO, Nurse, coordinationplanparkinson@chu-amiens.fr
- Recruiting
CHU Caen
Caen
carole fourniere, fourniere-c@chu-caen.fr
- Recruiting
CH de Dreux
Dreux
olivier Temgoua, doctor, otemgoua@chu-dreux.fr
- Recruiting
CHRU Lille
Lille
Audrey BENIEST, nurse, audrey.beniest@chru-lille.fr
- Recruiting
Hôpital St Vincent de Paul
Lille
lise DECLERCQ, nurse, isedep@ghicl.net
- Recruiting
Chu Rouen
Rouen
linda vernon, nurse, parkinson@chu-rouen.fr
- Recruiting
Clinique Saint Hilaire
Rouen
romain LEFAUCHEUR, Doctor, rlefaucheur@clinique-sainthilaire.fr
About this study
Treatment with subcutaneous apomorphine will be initiated according to the usual procedures at each centre. Once the patient is included in the study, he/she will be followed for 24 months according to a schedule of visits corresponding to his/her follow-up care.
The procedures outside of the patient's usual care are only more in-depth clinical assessments and examinations (interviews with a nurse, skin lesion assessment scale, quality of life scales, neurological and cognitive assessment scales).
Read more
At each visit, the patient will be seen in consultation by a state-qualified nurse from the neurology department who will conduct
- nursing interviews to assess tolerance and compliance with treatment. She will also look for data concerning the flow rate, the duration of the subcutaneous apomorphine pump and the injection methods (material used, rotation of injection sites, massages).
- collection of adverse effects and changes in concomitant treatments.
- assessment of skin complications (number, location, characteristics: size, pain, inflammation).
For centres that do not have a nurse dedicated to monitoring these patients, the above procedure will be carried out by the neurologist.
In all cases, the patient will receive a consultation (in the department or remotely) by the neurologist.
The tests and scales performed at inclusion will be repeated at each six-monthly visit.
- Being tested
- apomorphine pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apomorphine pumpDevice
observationnal
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of at least one painful
pain rating scale ≥ 1/10
Measured: up to 24 weeks
the occurence of treatment discontinuation
skin nodule any size
Measured: up to 24 weeks
Secondary outcomes (6)
Assessment of nodules
number, localisation
Measured: at stopping apomorphine
assessment of the pain of nodules or erythema
Visual Analogue Scale from 1 to 10:
Measured: up to 24 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
Measured: six-monthly visit
Hoehn and Yahr
Measured: six-monthly visit
Parkinson's Disease Questionnaire : quality of life scale,
Measured: six-monthly visit
Test of Montreal Cognitive Assessment
Measured: six-monthly visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Oct 2020
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Parkinson's Disease Treated With Apomorphine PumpsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331573
- Sponsor's protocol ID
- 2019/069/OB
- Acronym
- POLEMIC
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
- ClinicalTrials.gov ID
- NCT05331573
- Acronym / sponsor ID
- POLEMIC / 2019/069/OB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 15 Apr 2022 (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.
Treatment with subcutaneous apomorphine will be initiated according to the usual procedures at each centre. Once the patient is included in the study, he/she will be followed for 24 months according to a schedule of visits corresponding to his/her follow-up care.
The procedures outside of the patient's usual care are only more in-depth clinical assessments and examinations (interviews with a nurse, skin lesion assessment scale, quality of life scales, neurological and cognitive assessment scales).
At each visit, the patient will be seen in consultation by a state-qualified nurse from the neurology department who will conduct
- nursing interviews to assess tolerance and compliance with treatment. She will also look for data concerning the flow rate, the duration of the subcutaneous apomorphine pump and the injection methods (material used, rotation of injection sites, massages).
- collection of adverse effects and changes in concomitant treatments.
- assessment of skin complications (number, location, characteristics: size, pain, inflammation).
For centres that do not have a nurse dedicated to monitoring these patients, the above procedure will be carried out by the neurologist.
In all cases, the patient will receive a consultation (in the department or remotely) by the neurologist.
The tests and scales performed at inclusion will be repeated at each six-monthly visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease treated with apomorphine pumps
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years,
- Diagnosis of Parkinson's disease according to the MDS criteria (2015),
- Patients with a prescription for subcutaneous apomorphine pump therapy,
- Patient having read and understood the information letter and having expressed oral non-opposition to the research.
Key exclusion criteria (5 listed)
- Patient unable to express opposition or non-opposition,
- Patient not affiliated to the social security system,
- Pregnant woman or woman in labour or breastfeeding,
- Person deprived of liberty by an administrative or judicial decision,
- Person placed under court protection, guardianship or curatorship.
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 |
|---|---|---|
| apomorphine pumpobservationnal | Device | – |
Primary outcome
the occurrence of at least one painful
Time frame: up to 24 weeks
pain rating scale ≥ 1/10
the occurence of treatment discontinuation
Time frame: up to 24 weeks
skin nodule any size
6 secondary outcomes
Assessment of nodules
Time frame: at stopping apomorphine
assessment of the pain of nodules or erythema
Time frame: up to 24 weeks
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
Time frame: six-monthly visit
Hoehn and Yahr
Time frame: six-monthly visit
Parkinson's Disease Questionnaire : quality of life scale,
Time frame: six-monthly visit
Test of Montreal Cognitive Assessment
Time frame: six-monthly visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Parkinson's Disease Treated With Apomorphine Pumps, run by University Hospital, Rouen at 7 sites 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda VERNON, nurse ((+ 33) 2 32 88 14 46, parkison@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the occurrence of at least one painful (time frame: up to 24 weeks). 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 1 Sep 2022.