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
- Diseases
- Parkinson disease
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Pontchaillou Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.