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

Korábbi kezelés

• Previous use of apomorphine pump treatment,
• 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,

Más betegség

• 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,
• History of respiratory depression,
• History of deep brain stimulation or lesional surgery for PD or intrajejunal L-Dopa,
• Hypersensitivity to apomorphine or any excipients of the medicinal product,

Laborértékek

• 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),
• 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;

Egyéb

• Need for nursing care,
• Presence of severe freezing or clinically relevant postural instability leading to falls during the ON state,
• Symptomatic clinically relevant and medically uncontrolled orthostatic hypotension,
• Pregnant and breastfeeding women,
• Adults legally protected (under judicial protection, guardianship or supervision), persons deprived of their liberty.

• 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.