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

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ClinicalTrials.gov Identifier: NCT02864004
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE August 11, 2016
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE March 3, 2017
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
  • 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 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 [ 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)
Official Title  ICMJE Apomorphine Pump in Early Stage of Parkinson's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: Apomorphine
    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
    Other Name: Apokinon
  • Other: Best Medical Treatment
    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 Arms  ICMJE
  • Experimental: APO group
    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
    Intervention: Drug: Apomorphine
  • Active Comparator: Control group
    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: Other: Best Medical Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 3, 2024
Estimated Primary Completion Date March 3, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sophie DRAPIER, Dr +33 2 99 28 98 42 sophie.drapier@chu-rennes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02864004
Other Study ID Numbers  ICMJE 35RC15_9724_EARLY-PUMP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sophie DRAPIER, Dr Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP