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.
This Phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced Parkinson's disease (PD) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD. Further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced PD patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Loma Linda, California, United States
Unnamed facility
Los Angeles, California, United States
Percent of daily "off" time during the waking day
Time frame: Baseline Visit to Week 12
Percent daily "on" time without troublesome dyskinesias during waking day
Time frame: Baseline Visit to Week 12
Percent of daily "off" time during the waking day
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Percent of daily "on" time without troublesome dyskinesias during the waking day
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Percent of daily "on" time without dyskinesias
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Unified Parkinson's Disease Rating Scale - Motor Score
Time frame: Baseline Visit to Week 12
Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Parkinson's Disease Questionnaire
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
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Unnamed facility
Los Angeles, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Boca Raton, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Chicago, Illinois, United States
...and 8 more locations
United Parkinson's Disease Rating Scale - Activities of Daily Living Score
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Proportion of responders
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry
Time frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits