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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02864004
Other study ID # 35RC15_9724_EARLY-PUMP
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date March 3, 2017
Est. completion date January 30, 2025

Study information

Verified date November 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 134
Est. completion date January 30, 2025
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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:
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

Locations

Country Name City State
France Amiens University Hospital Amiens
France Bayonne Côte Basque Hospital Bayonne
France Pellegrin University Hospital Bordeaux
France Pierre Wertheimer Hospital Bron
France Caen University Hospital Caen
France Clermont-Ferrand University Hospital Clermont-Ferrand
France Lille University Hospital Lille
France APHM, hospital of Timone Marseille
France Clinique Beau-Soleil Montpellier
France Montpellier University Hospital Montpellier
France Nancy University Hospital Nancy
France Laennec Hospital Nantes
France Pasteur 2 University Hospital Nice
France Caremeau University Hospital Nîmes
France Pitié-Salpêtriere Hospital Paris
France Poitiers University Hospital Poitiers
France Rennes University Hospital Rennes
France Saint-Etienne University Hospital Saint- Etienne
France Hautepierre University Hospital Strasbourg
France Purpan University Hospital Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary Change in the Patient Global Impression of Change (PGIC) 12 months
Secondary Change in the Neurologist Global Impression of change (CGI-I) 12 months
Secondary 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 12 months
Secondary 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 12 months
Secondary Change in motor examination during "on" periods (MDS-UPDRS III) between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in motor complications with MDS-UPDRS IV between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in number of hours per day in the "best ON" state between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in number of hours per day in "ON" with dyskinesia between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in number of hours per day in "OFF" state between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in number of Sleeping-hours per day between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in Score of the Non-Motor Symptoms Scales (NMSS) for PD between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in psychosocial functioning PD (SCOPA-PS) between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Changes in score of depressive symptoms (BDI) between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in occurrence of anxiety (STAI-S) between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in pain assessed on the Visual Analog Scale (VAS) between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary 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 12 months
Secondary Change in apathy assessed on the Apathy Scale between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary 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 12 months
Secondary Change of dose for treatments assessed by levodopa (L-DOPA) equivalents between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Change in behavioral symptoms assessed by Ardouin Scale between the baseline assessment and the assessment at 12 months' follow up 12 months
Secondary Frequency, type and severity of therapy-related adverse events 12 months
Secondary Skin changes assessed by a clinical exam 12 months
Secondary Full blood count 12 months
Secondary Epworth Sleepiness Scale 12 months
Secondary Incremental Cost-Effectiveness Ratio (ICER) 24 months
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