Active, not recruiting
Phase 3
Infusion of Apomorphine: Long-term Safety Study
Condition(s) studied
Idiopathic Parkinson's Disease
Investigational drug(s) / intervention(s)
apomorphine infusion
apomorphine infusion: Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Study 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.
Eligibility
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
Primary outcome measure(s)
- Percent of daily "off" time during the waking day — Baseline Visit to Week 12
Trial sites (18)
| Facility | City | Region | Status |
| — |
Phoenix |
Arizona |
|
| — |
Loma Linda |
California |
|
| — |
Los Angeles |
California |
|
| — |
Los Angeles |
California |
|
| — |
Aurora |
Colorado |
|
| — |
Englewood |
Colorado |
|
| — |
Boca Raton |
Florida |
|
| — |
Atlanta |
Georgia |
|
| — |
Augusta |
Georgia |
|
| — |
Chicago |
Illinois |
|
| — |
Chicago |
Illinois |
|
| — |
Kansas City |
Kansas |
|
| — |
West Bloomfield |
Michigan |
|
| — |
Albany |
New York |
|
| — |
Cincinnati |
Ohio |
|
| Portland VA Medical Center |
Portland |
Oregon |
|
| — |
Philadelphia |
Pennsylvania |
|
| — |
Kirkland |
Washington |
|