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 range
30 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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