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

STATUS

Recruiting
participants needed

192
sponsor

Rennes University Hospital

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Updated on 19 February 2024

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parkinson's disease

parkinsonism

dyskinesia

medical therapy

apomorphine

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.

Details

Condition	Parkinson's Disease, Parkinson's Disease
Age	18-65 years
Treatment	Apomorphine, Best Medical Treatment
Clinical Study Identifier	NCT02864004
Sponsor	Rennes University Hospital
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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