Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)
NCT ID: NCT02864004
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
134 participants
INTERVENTIONAL
2017-03-03
2025-01-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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.
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Sophie DRAPIER, Dr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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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, , France
Countries
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Other Identifiers
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35RC15_9724_EARLY-PUMP
Identifier Type: -
Identifier Source: org_study_id