Apomorphine Pump in Early Stage of Parkinson’s Disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 dyskinesia 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 components of the study,
- Written informed consent,
- Patients covered with social insurance.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 192
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Dementia (MoCA score < 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, ALT and 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 QTsyndrome; or >450 ms absolute duration,
- Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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