Clinical trial

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

Name

35RC21_9909_PHARM-APO

Description

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.

Trial arms

Trial start

2021-09-16

Estimated PCD

2024-09-16

Trial end

2024-09-16

Status

Recruiting

Phase

Early phase I

Treatment

Apomorphine

Assigned Interventions: * blood sampling * blood collection * systolic, diastolic, mean blood pressure and heart rate measure

Arms:

Patients with Parkinson disease

Size

Primary endpoint

Area under the curve of plasma apomorphine concentration between 0h and 24h

up to 24 hours

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

Updated at

2024-04-16

1 organization

1 product

1 indication

Organization

Rennes University Hospital

Product

Apomorphine

Indication

Parkinson's disease