Infusion of Apomorphine: Long-term Safety Study

Korábbi kezelés

• Recent history (within the previous 12 months) of alcohol or substance abuse
• History of previously treated or current diagnosis of malignant melanoma

Más betegség

• Planned surgical intervention for the treatment of Parkinson's disease during participation in the study
• History of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists
• Exhibits certain signs and symptoms of cardiovascular disease

Laborértékek

• History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite

Egyéb

• Known, suspected, or planned pregnancy or lactation.
• Other criteria will be discussed in detail with potential subjects by site Investigator

• Advanced idiopathic PD consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
• Overall motor control is unsatisfactory in the opinion of the Investigator and subject despite optimized treatment with available therapies, which must include a stable regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the following other classes of therapies:
• Dopamine agonists (note: APOKYN intermittent injection is not to be considered here)
• Monoamine oxidase B [MAO B] inhibitors
• Catechol-O-methyltransferase (COMT) inhibitors
• Deep brain stimulation (DBS)
• Levodopa/carbidopa intestinal gel surgery (Duopa, Duodopa)
• Other - amantadine at doses of up to 400 mg per day)
• Experiences "off" periods averaging ≥3.0 hours per waking day
• Other criteria will be discussed in detail with potential subjects by site Investigator