Status:
COMPLETED
Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease
Lead Sponsor:
Rennes University Hospital
Conditions:
Parkinson Disease
Eligibility:
MALE
50-70 years
Phase:
PHASE4
Brief Summary
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 stabili...
Detailed Description
A screening visit will be conducted 15 days to 2 months prior to the patient's hospitalization. Each subject will undergo a clinical examination including a collection of data relating to medical and ...
Eligibility Criteria
Inclusion
- 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))
Exclusion
- 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)
- Clinically relevant renal dysfunction that may significantly alter drug excretion (clearance \< 30 mL/min (chronic renal failure))
- Alcohol abuse (\> 30 g pure alcohol per day\*) or drug addiction
- Current tobacco consumption ; for ex-smokers : stopping smoking for less than 1 month at the time of inclusion
- Dementia or cognitive impairment considered clinically significant
- Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04887467
Start Date
September 16 2021
End Date
July 22 2024
Last Update
May 30 2025
Active Locations (1)
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1
CHU Pontchaillou
Rennes, France, 35033