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

Korábbi kezelés

• 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

Más betegség

• Dementia or cognitive impairment considered clinically significant

Laborértékek

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

Egyéb

• 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

• 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))