Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions

Recruiting

• Conditions: Patients With Parkinson's Disease Treated With Apomorphine Pumps

• Registration Number: NCT05331573
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-15
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the occurrence of at least one painful	up to 24 weeks	pain rating scale ≥ 1/10
the occurence of treatment discontinuation	up to 24 weeks	skin nodule any size

Secondary Outcome Measures

Name	Time	Method
Assessment of nodules	at stopping apomorphine	number, localisation
Parkinson's Disease Questionnaire : quality of life scale,	six-monthly visit
Hoehn and Yahr	six-monthly visit
Test of Montreal Cognitive Assessment	six-monthly visit
Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale	six-monthly visit
assessment of the pain of nodules or erythema	up to 24 weeks	Visual Analogue Scale from 1 to 10:

Trial Locations

Locations (7)

CHU Caen; 🇫🇷 Caen, France

Chu Rouen; 🇫🇷 Rouen, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

CHU Amien; 🇫🇷 Amiens, France

CH de Dreux; 🇫🇷 Dreux, France

CHRU Lille; 🇫🇷 Lille, France

Hôpital St Vincent de Paul; 🇫🇷 Lille, France