Parkinson's DiseasePhase 3EARLY-PUMPNCT02864004
Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)
A Phase 3 study testing Apomorphine and Best Medical Treatment in people with Parkinson's Disease, run by Rennes University Hospital at 20 sites in France.
Trial summary
The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Apomorphine and Best Medical Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 20 sitesFrance
- Study dates
- 3 Mar 2017to 10 Jan 2025
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≤ 65 years,
- Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of Parkinsonism,
- Hoehn and Yahr stage ≤ 2.5 in the best ON,
- Disease duration ≥ 4 years,
- Presence of fluctuations and/or dyskinesias for no more than 3 years,
- One of the two following forms of impairment :
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- Impairment in activities of daily living (MDS-UPDRS II>6) due to PD-symptoms despite medical treatment in the worst condition or,
- Impairment of social and occupational functioning (measured with SOFAS) due to PD-symptoms despite medical treatment (51-80%),
- PDQ39 completed,
- Able to understand and remember the component of the study,
- Written informed consent,
- Patients covered with social insurance.
Who cannot join
- Dementia (MoCA < 22),
- Major uncontrolled depression at the time of assessment (BDI > 25) or Bipolar disease,
- Active hallucinations or history of hallucinations in the past year,
- Need for nursing care,
- Previous use of apomorphine pump treatment,
- History of respiratory depression,
Show all 17Show fewer
- History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,
- Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state,
- Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,
- Clinically relevant hepatic dysfunction (total bilirubin >2.0 mg/dL, Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) >2 times the upper limit of normal),
- Clinically relevant renal dysfunction (serum creatinine >2.0 mg/dL),
- Pregnant and breastfeeding women,
- Hypersensitivity to apomorphine or any excipients of the medicinal product,
- Concomitant therapy or within 28 days prior to baseline with : alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except Clozapine), methylphenidate, or amphetamine, intrajejunal Ldopa,
- History or current drug or alcohol abuse or dependencies,
- Patients with a borderline QT interval corrected for heart rate according to Bazett's formula (QTc) of >470 ms for male and >480 ms for female at screening or history of long QT syndrome;
- Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Amiens University Hospital
Amiens, 80054
Bayonne Côte Basque Hospital
Bayonne, 64109
Pellegrin University Hospital
Bordeaux, 33000
Pierre Wertheimer Hospital
Bron, 69677
Caen University Hospital
Caen, 14033
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003
Lille University Hospital
Lille, 59037
APHM, hospital of Timone
Marseille, 13385
Clinique Beau-Soleil
Montpellier, 34070
Montpellier University Hospital
Montpellier, 34295
Nancy University Hospital
Nancy, 54035
Laennec Hospital
Nantes, 44093
Pasteur 2 University Hospital
Nice, 06002
Caremeau University Hospital
Nîmes, 30029
Pitié-Salpêtriere Hospital
Paris, 75651
Poitiers University Hospital
Poitiers, 86021
Rennes University Hospital
Rennes, 35033
Saint-Etienne University Hospital
Saint-Etienne, 42055
Hautepierre University Hospital
Strasbourg, 67098
Purpan University Hospital
Toulouse, 31059
About this study
Official title: Apomorphine Pump in Early Stage of Parkinson's Disease
The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.
Read the detailed description
The recruitment period will be 36 months. The duration of the study period will be one year for each patient due to:
- adjustments of apomorphine pump parameters and oral medication (3 months interval),
- motor and psychosocial changes which need time to develop and have an impact on QoL.
At the end of the study period, two additional visits at Months 18 and 24 will be performed during an long term follow up to collect QoL and costs related data required to medico-economic analysis.
APOMORPHINE (APO) group:
The apomorphine pump will be installed and adjusted at baseline during a first hospitalization (10 days). Modifications of the hourly flow of the pump and readjustment (reduction) of anti-parkinsonian oral medication will be checked and performed at Months 1, 2, 4, 5, 6, 9 during visits and phone calls, and at month 3 during a 3 days hospitalization. Clinical evaluations will be performed at months 6 and 12.
Control group:
Patients will be treated by optimized medical treatment according to the guidelines of the European Federation of Neurological Societies. Dose adjustments will be done at Months 3, 6, 9. Clinical evaluations will be performed at months 6 and 12.
In both groups, data for medico-economic evaluation will be collected from patients at baseline, Months 6, 12, 18 and 24 for Quality Adjusted Life Year (QALYs) and costs related data from a patient's diary and French Health Insurance database.
- Conditions
- Parkinson's Disease
- Being tested
- Apomorphine, Best Medical Treatment
- Keywords
- Parkinson disease, Quality of Life, Apomorphine infusion
- 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
Also called Apokinon
Apomorphine (5 mg/ml) is supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate is adjusted during the whole duration of the study to doses of minimum 3 mg/hour up to a maximum of 10 mg/hour
Best Medical TreatmentOther
Most efficient single treatment of Parkinson's disease symptoms or their combinations, in concordance with the guidelines of the European Federation of Neurological Societies
| Study group | Role | What they receive |
|---|---|---|
| APO group | Experimental | An apomorphine pump will be installed and adjusted. The target dose corresponds to the patient's individual optimized dose :maximum dose of 10 mg/hour for 16 hours Receives: Drug: Apomorphine |
| Control group | Active comparator | Patients will be optimally treated with oral dopaminergic therapy to obtain the best medical treatment (BMT) defined as the most efficient single treatment options or their combination. Receives: Other: Best Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) summary index between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Secondary outcomes (25)
Change in the Patient Global Impression of Change (PGIC)
Measured: 12 months
Change in the Neurologist Global Impression of change (CGI-I)
Measured: 12 months
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in motor examination during "on" periods (MDS-UPDRS III) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in number of hours per day in the "best ON" state between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in number of hours per day in "ON" with dyskinesia between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in number of hours per day in "OFF" state between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in Score of the Non-Motor Symptoms Scales (NMSS) for PD between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in pain assessed on the Visual Analog Scale (VAS) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in cognitive function between the baseline assessment and the assessment at 12 months' follow up
Change in cognitive function assessed by the Neuroscience Parkinson network's (NS-PARK) battery test
Measured: 12 months
Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in apathy assessed on the short version of Lille Apathy Rating Scale (LARS) between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change of dose for treatments assessed by levodopa (L-DOPA) equivalents between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up
Measured: 12 months
Frequency, type and severity of therapy-related adverse events
Measured: 12 months
Skin changes assessed by a clinical exam
Measured: 12 months
Full blood count
Measured: 12 months
Epworth Sleepiness Scale
Measured: 12 months
Incremental Cost-Effectiveness Ratio (ICER)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start3 Mar 2017
- Primary completion12 Jan 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie DRAPIER, Dr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864004
- Sponsor's protocol ID
- 35RC15_9724_EARLY-PUMP
- Acronym
- EARLY-PUMP
- Status last verified
- Jun 2026
- First submitted
- 15 Jul 2016
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apomorphine Pump in Early Stage of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02864004
- Acronym / sponsor ID
- EARLY-PUMP / 35RC15_9724_EARLY-PUMP
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson disease, Quality of Life, Apomorphine infusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
The aim of the study is to assess the use of the apomorphine pump in earlier stages of Parkinson' Disease (PD), when motor complications have just developed and before patients are significantly affected in their social and occupational functioning. The investigators hypothesize that apomorphine pump is superior in terms of positive impact on quality of life (QoL) to oral medical therapy alone at a relatively early stage of PD, before the appearance of severe disabling motor complications thus favoring the maintain of patients' social and occupational status with a significant positive economic impact of the health system.
Detailed description
The recruitment period will be 36 months. The duration of the study period will be one year for each patient due to:
- adjustments of apomorphine pump parameters and oral medication (3 months interval),
- motor and psychosocial changes which need time to develop and have an impact on QoL.
At the end of the study period, two additional visits at Months 18 and 24 will be performed during an long term follow up to collect QoL and costs related data required to medico-economic analysis.
APOMORPHINE (APO) group:
The apomorphine pump will be installed and adjusted at baseline during a first hospitalization (10 days). Modifications of the hourly flow of the pump and readjustment (reduction) of anti-parkinsonian oral medication will be checked and performed at Months 1, 2, 4, 5, 6, 9 during visits and phone calls, and at month 3 during a 3 days hospitalization. Clinical evaluations will be performed at months 6 and 12.
Control group:
Patients will be treated by optimized medical treatment according to the guidelines of the European Federation of Neurological Societies. Dose adjustments will be done at Months 3, 6, 9. Clinical evaluations will be performed at months 6 and 12.
In both groups, data for medico-economic evaluation will be collected from patients at baseline, Months 6, 12, 18 and 24 for Quality Adjusted Life Year (QALYs) and costs related data from a patient's diary and French Health Insurance database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APO group | Experimental | Drug: ApomorphineAn apomorphine pump will be installed and adjusted. The target dose corresponds to the patient's individual optimized dose :maximum dose of 10 mg/hour for 16 hours |
| Control group | Active comparator | Other: Best Medical TreatmentPatients will be optimally treated with oral dopaminergic therapy to obtain the best medical treatment (BMT) defined as the most efficient single treatment options or their combination. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged ≤ 65 years,
- Idiopathic PD (According to British Brain Bank Criteria) without any other known or suspected cause of Parkinsonism,
- Hoehn and Yahr stage ≤ 2.5 in the best ON,
- Disease duration ≥ 4 years,
- Presence of fluctuations and/or dyskinesias for no more than 3 years,
Key exclusion criteria (17 listed)
- Dementia (MoCA < 22),
- Major uncontrolled depression at the time of assessment (BDI > 25) or Bipolar disease,
- Active hallucinations or history of hallucinations in the past year,
- Need for nursing care,
- Previous use of apomorphine pump treatment,
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 |
|---|---|---|
| ApomorphineAlso: ApokinonApomorphine (5 mg/ml) is supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate is adjusted during the whole duration of the study to doses of minimum 3 mg/hour up to a maximum of 10 mg/hour | Drug | APO group |
| Best Medical TreatmentMost efficient single treatment of Parkinson's disease symptoms or their combinations, in concordance with the guidelines of the European Federation of Neurological Societies | Other | Control group |
Primary outcome
Difference in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) summary index between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
25 secondary outcomes
Change in the Patient Global Impression of Change (PGIC)
Time frame: 12 months
Change in the Neurologist Global Impression of change (CGI-I)
Time frame: 12 months
Change in non-motor aspects of experiences of daily living (MDS-UPDRS I) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in motor aspects of experiences of daily in "on" and "off" medication (MDS-UPDRS II) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in motor examination during "on" periods (MDS-UPDRS III) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in number of hours per day in the "best ON" state between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in number of hours per day in "ON" with dyskinesia between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in number of hours per day in "OFF" state between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in Score of the Non-Motor Symptoms Scales (NMSS) for PD between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in pain assessed on the Visual Analog Scale (VAS) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in cognitive function between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in apathy assessed on the short version of Lille Apathy Rating Scale (LARS) between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change of dose for treatments assessed by levodopa (L-DOPA) equivalents between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up
Time frame: 12 months
Frequency, type and severity of therapy-related adverse events
Time frame: 12 months
Skin changes assessed by a clinical exam
Time frame: 12 months
Full blood count
Time frame: 12 months
Epworth Sleepiness Scale
Time frame: 12 months
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: 24 months
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 16 Jun 2026.
- 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.
Sophie DRAPIER, Dr principal investigator
Rennes University Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apomorphine and Best Medical Treatment in people with Parkinson's Disease, run by Rennes University Hospital at 20 sites 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 12 inclusion and 17 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Difference in the Parkinson's Disease Quality of Life Questionnaire (PDQ39) summary index between the baseline assessment and the assessment at 12 months' follow up (time frame: 12 months). 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 16 Jun 2026.