Infusion of Apomorphine: Long-term Safety Study (NCT02339064) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Infusion of Apomorphine: Long-term Safety Study
United States99 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sign…
What they're measuring
1
Percent of daily "off" time during the waking day
Timeframe: Baseline Visit to Week 12
Trial details
NCT IDNCT02339064
SponsorMDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals