Apomorphine Pump in Early Stage of Parkinson's Disease

35RC15_9724_EARLY-PUMP

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.

2017-03-03

2023-12-31

2025-01-30

Active (not recruiting)

Early phase I

134

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 134, 'type': 'ACTUAL'}}

2023-11-27