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ClinicalTrials.gov ID

NCT05331573

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

108Estimated

Last Update Posted

Sep 1, 2022Actual

Start Date

Oct 1, 2020Actual

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2024Estimated

Official Title

Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions

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.

• Patients With Parkinson's Disease Treated With Apomorphine Pumps

• apomorphine pump

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital, RouenOTHER

fourniere-c@chu-caen.fr

otemgoua@chu-dreux.fr

audrey.beniest@chru-lille.fr

parkinson@chu-rouen.fr