Idiopathic Parkinson's Disease
Conditions
Keywords
Parkinson's disease,, apomorphine, Apokyn, dopamine agonist, levodopa, advanced, PD, carbidopa, pramipexole, ropinirole, rotigotine, MAO-B inhibitors, COMT inhibitors, off, dyskinesia
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.
Detailed description
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.
Interventions
DRUGapomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Sponsors
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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 Investigator
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 Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of daily off time during the waking day | Baseline Visit to Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Percent of daily off time during the waking day | 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 | 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 | 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 | Baseline Visit to Week 12 |
| Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale | Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits |
| Percent daily on time without troublesome dyskinesias during waking day | Baseline Visit to Week 12 |
| Parkinson's Disease Questionnaire | Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits |
| United Parkinson's Disease Rating Scale - Activities of Daily Living Score | Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits |
| Proportion of responders | 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 | 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 | Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits |
Countries
United States
Outcome results
None listed