Infusion of Apomorphine: Long-term Safety Study

Running, not enrolling · Phase 3

Conditions studied: Idiopathic Parkinson's Disease

In brief

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.

Key facts

Study ID

NCT02339064

Run by

MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

People needed

99

Starts

2015-02-01

Expected to finish

2025-12-01

Last updated by the study team

2025-06-19

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Englewood, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — Albany, New York, United States
• Study site — Cincinnati, Ohio, United States
• Portland VA Medical Center — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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