NCT02339064Active, not recruitingPhase 3
Infusion of Apomorphine: Long-term Safety Study
A Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available Therapy
Source: ClinicalTrials.gov · Last updated 19 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 31 Mar 2014
- Start date
- Feb 2015
- Primary completion date
- Dec 2018
- Lead sponsor
- MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
- Diseases
- Parkinson disease
- NCT number
- NCT02339064
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 99
- From Feb 2015 to the primary completion date, Dec 2018
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent history (within the previous 12 months) of alcohol or substance abuse
- History of previously treated or current diagnosis of malignant melanoma
Other illness
- Planned surgical intervention for the treatment of Parkinson's disease during participation in the study
- History of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists
- Exhibits certain signs and symptoms of cardiovascular disease
Lab values
- History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite
Other
- Known, suspected, or planned pregnancy or lactation.
- Other criteria will be discussed in detail with potential subjects by site Investigator
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.