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A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson’s Disease Patients With Unsatisfactory Control on Available Therapy


Brief Summary:

This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous
apomorphine infusion in subjects with advanced Parkinson’s Disease (PD) whose motor
fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one
other class of drugs or mode of therapy for PD.


Inclusion Criteria:

– 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

Exclusion Criteria:

– Planned surgical intervention for the treatment of Parkinson’s disease during
participation in the study

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

– Known, suspected, or planned pregnancy or lactation.

– Recent history (within the previous 12 months) of alcohol or substance abuse

– History of impulsive/compulsive behaviors primarily associated with the use of
dopamine agonists

– History of previously treated or current diagnosis of malignant melanoma

– Exhibits certain signs and symptoms of cardiovascular disease

– Other criteria will be discussed in detail with potential subjects by site


  • , Loma Linda, California, United States, 92354
  • , Los Angeles, California, United States, 90033
  • , Los Angeles, California, United States, 90095
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