Parkinson DiseasePhase 4PHARM-APONCT04887467
Monocentric, Prospective Study to Assess the Pharmacokinetic Profile of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease
A Phase 4 study testing Apomorphine in people with Parkinson Disease, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Apomorphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2021to 22 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.
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.
Read the 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 surgical history, specific data related to Parkinson's disease and apomorphine pump treatment, and the completion of all items of the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 3 scale in ON condition. Verification of the biological parameters necessary for the proper conduct of a pharmacokinetic study will also be carried out (venous capital; search for possible hepatic and/or renal failure).
The subjects will be called to the hospital two by two at 4:00 pm for a medical visit, during which a clinical examination will be performed (height, weight, fat mass, occurrence of infectious and/or inflammatory episodes) The subjects will then be placed in a room. A catheter will be placed in a forearm vein to allow blood sampling. All plasma samples will be taken from subjects who have been supine for at least 30 minutes. Blood pressure and heart rate will be checked before each sample.
A first blood sample will be taken at 8 pm followed by a standardized dinner. After the pump is stopped and removed at the patient's usual time, consecutive blood samples will be taken at T30, T60, T120, and T180 (i.e., 30 min, 1 h, 2 h, and 3 h after pump removal). The next morning, a new blood sample will be taken 10 min before the pump is turned on, at the usual time. A standardized breakfast will be served. A new series of consecutive blood samples will be taken at T30, T60, T120 and T180, following the same pattern as before.
A standardized lunch will be served around 11:30 am, and the patients will be allowed to leave after medical advice, at the latest at 2 pm.
- Conditions
- Parkinson Disease
- Being tested
- Apomorphine
- Keywords
- Apomorphine, Pharmacokinetics, Dopamine Agonists
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApomorphineDrug
Assigned Interventions:
- blood sampling
- blood collection
- systolic, diastolic, mean blood pressure and heart rate measure
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson disease | Experimental | Apomorphine 5mg/mL, solution for infusion, intraveinous use Receives: Drug: Apomorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of plasma apomorphine concentration between 0h and 24h
Measured: up to 24 hours
Secondary outcomes (11)
Systolic blood pressure variations measured prior to each blood collection
Measured: up to 24 hours
Diastolic blood pressure variations measured prior to each blood collection
Measured: up to 24 hours
Mean blood pressure variations measured prior to each blood collection
Measured: up to 24 hours
Heart rate variations measured prior to each blood collection
Measured: up to 24 hours
Area under the curve of plasma apomorphine concentration - time values curve from treatment administration (t0) until 6h after (AUC0-6)
Measured: up to 24 hours
Half-life (t1/2) determined by the t1/2 = Ln2/λz formula
Measured: up to 24 hours
Apparent total clearance (Cl/F) and apparent volume of distribution (Vd) calculated according to the formulas Cl/F = Dose/AUC0-24 et Vd = Cl(T)/λz wherein F is the absolute bioavailability
Measured: up to 24 hours
Study of weight on area under the curve of drug concentrations
Measured: up to 24 hours
Study of liver function on area under the curve of drug concentrations
Measured: up to 24 hours
Study of the main genes involved in the biotransformation and transport of apomorphine
DNA bank
Measured: up to 24 hours
Study of the pump type on area under the curve of drug concentrations
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start16 Sep 2021
- Primary completion22 Jun 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887467
- Sponsor's protocol ID
- 35RC21_9909_PHARM-APO
- Acronym
- PHARM-APO
- Status last verified
- May 2025
- First submitted
- 26 Apr 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Continuous and Diurnal Subcutaneous Apomorphine Infusion in Patients With Parkinson's Disease Under Stabilized Treatment.
- ClinicalTrials.gov ID
- NCT04887467
- Acronym / sponsor ID
- PHARM-APO / 35RC21_9909_PHARM-APO
- Conditions
- Parkinson Disease
- Keywords
- Apomorphine, Pharmacokinetics, Dopamine Agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 22 Jun 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 surgical history, specific data related to Parkinson's disease and apomorphine pump treatment, and the completion of all items of the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 3 scale in ON condition. Verification of the biological parameters necessary for the proper conduct of a pharmacokinetic study will also be carried out (venous capital; search for possible hepatic and/or renal failure).
The subjects will be called to the hospital two by two at 4:00 pm for a medical visit, during which a clinical examination will be performed (height, weight, fat mass, occurrence of infectious and/or inflammatory episodes) The subjects will then be placed in a room. A catheter will be placed in a forearm vein to allow blood sampling. All plasma samples will be taken from subjects who have been supine for at least 30 minutes. Blood pressure and heart rate will be checked before each sample.
A first blood sample will be taken at 8 pm followed by a standardized dinner. After the pump is stopped and removed at the patient's usual time, consecutive blood samples will be taken at T30, T60, T120, and T180 (i.e., 30 min, 1 h, 2 h, and 3 h after pump removal). The next morning, a new blood sample will be taken 10 min before the pump is turned on, at the usual time. A standardized breakfast will be served. A new series of consecutive blood samples will be taken at T30, T60, T120 and T180, following the same pattern as before.
A standardized lunch will be served around 11:30 am, and the patients will be allowed to leave after medical advice, at the latest at 2 pm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson disease | Experimental | Drug: ApomorphineApomorphine 5mg/mL, solution for infusion, intraveinous use |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApomorphineAssigned Interventions: * blood sampling * blood collection * systolic, diastolic, mean blood pressure and heart rate measure | Drug | Patients with Parkinson disease |
Primary outcome
Area under the curve of plasma apomorphine concentration between 0h and 24h
Time frame: up to 24 hours
11 secondary outcomes
Systolic blood pressure variations measured prior to each blood collection
Time frame: up to 24 hours
Diastolic blood pressure variations measured prior to each blood collection
Time frame: up to 24 hours
Mean blood pressure variations measured prior to each blood collection
Time frame: up to 24 hours
Heart rate variations measured prior to each blood collection
Time frame: up to 24 hours
Area under the curve of plasma apomorphine concentration - time values curve from treatment administration (t0) until 6h after (AUC0-6)
Time frame: up to 24 hours
Half-life (t1/2) determined by the t1/2 = Ln2/λz formula
Time frame: up to 24 hours
Apparent total clearance (Cl/F) and apparent volume of distribution (Vd) calculated according to the formulas Cl/F = Dose/AUC0-24 et Vd = Cl(T)/λz wherein F is the absolute bioavailability
Time frame: up to 24 hours
Study of weight on area under the curve of drug concentrations
Time frame: up to 24 hours
Study of liver function on area under the curve of drug concentrations
Time frame: up to 24 hours
Study of the main genes involved in the biotransformation and transport of apomorphine
Time frame: up to 24 hours
Study of the pump type on area under the curve of drug concentrations
Time frame: up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apomorphine in people with Parkinson Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of plasma apomorphine concentration between 0h and 24h (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.