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

NCT04887467 | Completed Phase 4

• 1 other identifier: 35RC21_9909_PHARM-APO
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 stabilized treatment and, secondly, to collect data highlighting the possible influence of pharmacogenetics.

Conditions

Parkinson Disease

Keywords

Apomorphine; Pharmacokinetics; Dopamine Agonists

Outcome Measures

Primary Outcomes (1)

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

  up to 24 hours

Secondary Outcomes (11)

• Systolic blood pressure variations measured prior to each blood collection

  up to 24 hours

• Diastolic blood pressure variations measured prior to each blood collection

  up to 24 hours

• Mean blood pressure variations measured prior to each blood collection

  up to 24 hours

• Heart rate variations measured prior to each blood collection

  up to 24 hours

• Area under the curve of plasma apomorphine concentration - time values curve from treatment administration (t0) until 6h after (AUC0-6)

  up to 24 hours

Study Arms (1)

Patients with Parkinson disease

EXPERIMENTAL

Apomorphine 5mg/mL, solution for infusion, intraveinous use

Drug: Apomorphine

Interventions

Apomorphine DRUG

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

Patients with Parkinson disease

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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
• Dementia or cognitive impairment considered clinically significant
• Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 14, 2021
• Study Start: September 16, 2021
• Primary Completion: June 22, 2024
• Study Completion: July 22, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)