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NCT04887467CompletedPhase 4

Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease

Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.

Source: ClinicalTrials.gov · Last updated 30 May 2025

Brief summary (registry, in English)

This monocentric and prospective trial aims firstly to assess the pharmacokinetic profile of continuous and diurnal subcutaneous apomorphine infusion in patients with Parkinson's disease under stabilized treatment and, secondly, to collect data highlighting the possible influence of pharmacogenetics.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
19 (actual)
First submitted
26 Apr 2021
Start date
16 Sept 2021
Primary completion date
22 Jun 2024
Lead sponsor
Rennes University Hospital
NCT number
NCT04887467

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 19
  • From 16 Sept 2021 to the primary completion date, 22 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant participation in a clinical trial that may affect the biological and/or pharmacokinetic parameters
  • Clinically relevant hepatic dysfunction that may significantly alter drug metabolism (value \>2 times the upper limit of normal)
  • Alcohol abuse (\> 30 g pure alcohol per day\*) or drug addiction

Other illness

  • Dementia or cognitive impairment considered clinically significant

Lab values

  • Clinically relevant renal dysfunction that may significantly alter drug excretion (clearance \< 30 mL/min (chronic renal failure))

Other

  • Current tobacco consumption ; for ex-smokers : stopping smoking for less than 1 month at the time of inclusion
  • Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty

Who the study is looking for

  • 50 to 70 year-old males
  • Suffering from Parkinson's disease, considered to be well controlled by treatment, including apomorphine (CGI criteria)
  • Use of daytime apomorphine pump treatment (nighttime discontinuation) for a minimum of 6 months, with a good tolerance and treatment dosage unchanged for a minimum of 3 months (apomorphine flow rate and daily dose and oral concomitant antiparkinsonian medication if applicable)
  • Autonomous patient in the apomorphine pump daily management (start and removal)
  • Written informed consent
  • Restrictive criteria to limit confounding factors : apomorphine type (Apokinon® apomorphine, cartridge or ampoule, Aguettant pharmaceutical laboratory) and medical device (Microjet CRONO-PAR pump (N=10) and France Développement Electronique (FDE) So Connect pump (N=10))

Age in the registry: 50 years to 70 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Pontchaillou
Coordinator of this site? Confirm its status
RennesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.