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Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (EARLY-PUMP)

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Apomorphine
Best Medical Treatment
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson disease, Quality of Life, Apomorphine infusion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 :

    • 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.

Exclusion Criteria:

  • 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,
  • 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.

Sites / Locations

  • Amiens University HospitalRecruiting
  • Bayonne Côte Basque HospitalRecruiting
  • Pellegrin University HospitalRecruiting
  • Pierre Wertheimer HospitalRecruiting
  • Caen University HospitalRecruiting
  • Clermont-Ferrand University HospitalRecruiting
  • Lille University HospitalRecruiting
  • APHM, hospital of TimoneRecruiting
  • Clinique Beau-SoleilRecruiting
  • Montpellier University HospitalRecruiting
  • Groupe Hospitalier Régional de Mulhouse et Sud Alsace
  • Nancy University HospitalRecruiting
  • Laennec HospitalRecruiting
  • Pasteur 2 University HospitalRecruiting
  • Caremeau University HospitalRecruiting
  • Pitié-Salpêtriere HospitalRecruiting
  • Poitiers University HospitalRecruiting
  • Rennes University HospitalRecruiting
  • Saint-Etienne University HospitalRecruiting
  • Hautepierre University HospitalRecruiting
  • Purpan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APO group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in the Patient Global Impression of Change (PGIC)
Change in the Neurologist Global Impression of change (CGI-I)
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
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
Change in motor examination during "on" periods (MDS-UPDRS III) between the baseline assessment and the assessment at 12 months' follow up
Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up
Change in number of hours per day in the "best ON" state between the baseline assessment and the assessment at 12 months' follow up
Change in number of hours per day in "ON" with dyskinesia between the baseline assessment and the assessment at 12 months' follow up
Change in number of hours per day in "OFF" state between the baseline assessment and the assessment at 12 months' follow up
Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up
Change in Score of the Non-Motor Symptoms Scales (NMSS) for PD between the baseline assessment and the assessment at 12 months' follow up
Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up
Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up
Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up
Change in pain assessed on the Visual Analog Scale (VAS) between the baseline assessment and the assessment at 12 months' follow up
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
Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up
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
Change of dose for treatments assessed by levodopa (L-DOPA) equivalents between the baseline assessment and the assessment at 12 months' follow up
Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up
Frequency, type and severity of therapy-related adverse events
Skin changes assessed by a clinical exam
Full blood count
Epworth Sleepiness Scale
Incremental Cost-Effectiveness Ratio (ICER)

Full Information

First Posted
July 15, 2016
Last Updated
October 19, 2021
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02864004
Brief Title
Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)
Acronym
EARLY-PUMP
Official Title
Apomorphine Pump in Early Stage of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson disease, Quality of Life, Apomorphine infusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APO group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apomorphine
Other Intervention Name(s)
Apokinon
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Best Medical Treatment
Intervention Description
Most efficient single treatment of Parkinson's disease symptoms or their combinations, in concordance with the guidelines of the European Federation of Neurological Societies
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in the Patient Global Impression of Change (PGIC)
Time Frame
12 months
Title
Change in the Neurologist Global Impression of change (CGI-I)
Time Frame
12 months
Title
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
Title
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
Title
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
Title
Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
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
Title
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
Title
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
Title
Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
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
Title
Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
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
Title
Change in cognitive function between the baseline assessment and the assessment at 12 months' follow up
Description
Change in cognitive function assessed by the Neuroscience Parkinson network's (NS-PARK) battery test
Time Frame
12 months
Title
Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
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
Title
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
Title
Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up
Time Frame
12 months
Title
Frequency, type and severity of therapy-related adverse events
Time Frame
12 months
Title
Skin changes assessed by a clinical exam
Time Frame
12 months
Title
Full blood count
Time Frame
12 months
Title
Epworth Sleepiness Scale
Time Frame
12 months
Title
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 : 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. Exclusion Criteria: 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sophie DRAPIER, Dr
Phone
+33 2 99 28 98 42
Email
sophie.drapier@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie DRAPIER, Dr
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa TIR, Dr
Facility Name
Bayonne Côte Basque Hospital
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie BANNIER, Dr
Facility Name
Pellegrin University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wassilios MEISSNER, Pr
Facility Name
Pierre Wertheimer Hospital
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloé LAURENCIN, Dr
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles DEFER, Pr
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck DURIF, Pr
Facility Name
Lille University Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc DEFEBVRE, Pr
Facility Name
APHM, hospital of Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre EUSEBIO, Dr
Facility Name
Clinique Beau-Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie COCHEN DE COCK, Dr
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria GONZALEZ, Dr
Facility Name
Groupe Hospitalier Régional de Mulhouse et Sud Alsace
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Nancy University Hospital
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Solène FRISMAND, Dr
Facility Name
Laennec Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiphaine ROUAUD, Dr
Facility Name
Pasteur 2 University Hospital
City
Nice
ZIP/Postal Code
06002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline GIORDANA, Dr
Facility Name
Caremeau University Hospital
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni CASTELNOVO, Dr
Facility Name
Pitié-Salpêtriere Hospital
City
Paris
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel FLAMAND ROZE, Pr
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle BENATRU, Dr
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie DRAPIER, Dr
Facility Name
Saint-Etienne University Hospital
City
Saint- Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domitille DILLY, Dr
Facility Name
Hautepierre University Hospital
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu ANHEIM, Pr
Facility Name
Purpan University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL-COURBON, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)

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