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Trial record 1 of 7 for:    apokyn | Recruiting Studies
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Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP) (EARLY-PUMP)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02864004
First received: July 15, 2016
Last updated: August 21, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Parkinson's Disease Drug: Apomorphine Other: Best Medical Treatment Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apomorphine Pump in Early Stage of Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

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 [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 192
Actual Study Start Date: March 3, 2017
Estimated Study Completion Date: September 3, 2021
Estimated Primary Completion Date: March 3, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
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

Detailed Description:

The recruitment period will be 24 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 >450 ms for male and >470 ms for female at screening or history of long QT syndrome; or >450 ms absolute duration,
  • Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02864004

Contacts
Contact: Sophie DRAPIER, Dr +33 2 99 28 98 42 sophie.drapier@chu-rennes.fr

Locations
France
Aix en Provence Hospital Not yet recruiting
Aix en Provence, France, 13616
Contact: François VIALLET, Dr         
Amiens University Hospital Not yet recruiting
Amiens, France, 80054
Contact: Pierre KRYSTKOWIAK, Pr         
Pellegrin University Hospital Not yet recruiting
Bordeaux, France, 33000
Contact: Wassilios MEISSNER, Pr         
Caen University Hospital Active, not recruiting
Caen, France, 14033
Clermont-Ferrand University Hospital Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Franck DURIF, Pr         
Dijon University Hospital Not yet recruiting
Dijon, France, 21079
Contact: Lucie MAUGEST, Dr         
Lille University Hospital Not yet recruiting
Lille, France, 59037
Contact: Luc DEFEBVRE, Pr         
Dupuytren University Hospital Not yet recruiting
Limoges, France, 87042
Contact: Frédéric TORNY, Dr         
APHM, hospital of Timone Not yet recruiting
Marseille, France, 13385
Contact: Alexandre EUSEBIO, Dr         
Clinique Beau-Soleil Recruiting
Montpellier, France, 34070
Contact: Valérie COCHEN DE COCK, Dr         
Montpellier University Hospital Active, not recruiting
Montpellier, France, 34295
Laennec Hospital Active, not recruiting
Nantes, France, 44093
Pasteur 2 University Hospital Active, not recruiting
Nice, France, 06002
Caremeau University Hospital Recruiting
Nîmes, France, 30029
Contact: Giovanni CASTELNOVO, Dr         
Pitié-Salpêtriere Hospital Not yet recruiting
Paris, France, 75651
Contact: Emmanuel FLAMAND ROZE, Pr         
Poitiers University Hospital Not yet recruiting
Poitiers, France, 86021
Contact: Isabelle BENATRU, Dr         
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Sophie DRAPIER, Dr         
Saint-Etienne University Hospital Not yet recruiting
Saint- Etienne, France, 42055
Contact: Domitille DILLY, Dr         
Hautepierre University Hospital Not yet recruiting
Strasbourg, France, 67098
Contact: Mathieu ANHEIM, Pr         
Foch Hospital Not yet recruiting
Suresnes, France, 92151
Contact: Frédéric BOURDAIN, Dr         
Purpan University Hospital Not yet recruiting
Toulouse, France, 31059
Contact: Christine BREFEL-COURBON, Dr         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Sophie DRAPIER, Dr Rennes University Hospital
  More Information

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02864004     History of Changes
Other Study ID Numbers: 35RC15_9724_EARLY-PUMP
Study First Received: July 15, 2016
Last Updated: August 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
Parkinson disease
Quality of Life
Apomorphine infusion

Additional relevant MeSH terms:
Apomorphine
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017