Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions (POLEMIC)

August 29, 2022 updated by: University Hospital, Rouen

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Parkinson's disease treated with apomorphine pumps

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the occurrence of at least one painful
Time Frame: up to 24 weeks
pain rating scale ≥ 1/10
up to 24 weeks
the occurence of treatment discontinuation
Time Frame: up to 24 weeks
skin nodule any size
up to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 11, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/069/OB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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