Clinical trial NCT05331573: Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
Official title: Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients With Parkinson's Disease Treated With Apomorphine Pumps
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease treated with apomorphine pumps

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: the occurrence of at least one painful
timeFrame: up to 24 weeks
measure: the occurence of treatment discontinuation
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Assessment of nodules
timeFrame: at stopping apomorphine
measure: assessment of the pain of nodules or erythema
timeFrame: up to 24 weeks
measure: Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
timeFrame: six-monthly visit
measure: Hoehn and Yahr
timeFrame: six-monthly visit
measure: Parkinson's Disease Questionnaire : quality of life scale,
timeFrame: six-monthly visit
measure: Test of Montreal Cognitive Assessment
timeFrame: six-monthly visit
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amien
city: Caen
country: France
facility: CHU Caen
city: Dreux
country: France
facility: CH de Dreux
city: Lille
country: France
facility: CHRU Lille
city: Lille
country: France
facility: Hôpital St Vincent de Paul
city: Rouen
country: France
facility: Chu Rouen
city: Rouen
country: France
facility: Clinique Saint Hilaire
Study officials:
References: