Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
99 participants
INTERVENTIONAL
2015-02-28
2025-12-31
Brief Summary
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Detailed Description
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Further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced PD patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Apomorphine infusion
Continuous subcutaneous apomorphine infusion
apomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Interventions
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apomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Eligibility Criteria
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Inclusion 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
* 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
30 Years
ALL
No
Sponsors
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MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gianpiera Ceresoli-Borroni, PhD
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
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Phoenix, Arizona, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Boca Raton, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
West Bloomfield, Michigan, United States
Albany, New York, United States
Cincinnati, Ohio, United States
Portland VA Medical Center
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Kirkland, Washington, United States
Countries
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Other Identifiers
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USWM-AP2-3000
Identifier Type: -
Identifier Source: org_study_id
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