Infusion of Apomorphine: Long-term Safety Study
INFUS-ON
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
1 other identifier
interventional
99
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2015
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJune 19, 2025
June 1, 2025
3.8 years
March 31, 2014
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of daily "off" time during the waking day
Baseline Visit to Week 12
Secondary Outcomes (11)
Percent daily "on" time without troublesome dyskinesias during waking day
Baseline Visit to Week 12
Percent of daily "off" time during the waking day
Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Percent of daily "on" time without troublesome dyskinesias during the waking day
Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Percent of daily "on" time without dyskinesias
Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Unified Parkinson's Disease Rating Scale - Motor Score
Baseline Visit to Week 12
- +6 more secondary outcomes
Study Arms (1)
Apomorphine infusion
EXPERIMENTALContinuous subcutaneous apomorphine infusion
Interventions
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Phoenix, Arizona, 85013, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Englewood, Colorado, 80113, United States
Unknown Facility
Boca Raton, Florida, 33486, United States
Unknown Facility
Atlanta, Georgia, 30329, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
West Bloomfield, Michigan, 48322, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Portland VA Medical Center
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Kirkland, Washington, 98034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gianpiera Ceresoli-Borroni, PhD
Supernus Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2014
First Posted
January 15, 2015
Study Start
February 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2025
Last Updated
June 19, 2025
Record last verified: 2025-06