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NCT05331573: POLEMIC

Parkinsonian Patients Treated With Apomorphine Pump: Observatory of Skin Lesions

Status unknown Last updated 1 September 2022
What this trial tests

trial testing apomorphine pump in Patients With Parkinson's Disease Treated With Apomorphine Pumps in 108 participants. Status unknown.

Timeline
1 October 2020
Primary endpoint
1 October 2024
1 October 2024

Quick facts

Lead sponsorUniversity Hospital, Rouen
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment108
Start date1 October 2020
Primary completion1 October 2024
Estimated completion1 October 2024
Sites7 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Rouen

Who can join

18 and older, any sex, with Patients With Parkinson's Disease Treated With Apomorphine Pumps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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