Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT04887467
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT04887467
Study Brief:
Protocol Section:
NCT04887467