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Trial record 1 of 1 for:    NCT02339064
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Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)

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ClinicalTrials.gov Identifier: NCT02339064
Recruitment Status : Unknown
Verified November 2020 by USWM, LLC (dba US WorldMeds).
Recruitment status was:  Active, not recruiting
First Posted : January 15, 2015
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
USWM, LLC (dba US WorldMeds)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Drug: apomorphine infusion Phase 3

Detailed Description:

This Phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced Parkinson's disease (PD) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Apomorphine infusion
Continuous subcutaneous apomorphine infusion
 Drug: apomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device


Outcome Measures
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Primary Outcome Measures :
  1. Percent of daily "off" time during the waking day [ Time Frame: Baseline Visit to Week 12 ]

Secondary Outcome Measures :
  1. Percent daily "on" time without troublesome dyskinesias during waking day [ Time Frame: Baseline Visit to Week 12 ]
  2. Percent of daily "off" time during the waking day [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  3. Percent of daily "on" time without troublesome dyskinesias during the waking day [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  4. Percent of daily "on" time without dyskinesias [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  5. Unified Parkinson's Disease Rating Scale - Motor Score [ Time Frame: Baseline Visit to Week 12 ]
  6. Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  7. Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  8. Parkinson's Disease Questionnaire [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  9. United Parkinson's Disease Rating Scale - Activities of Daily Living Score [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  10. Proportion of responders [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]
  11. Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry [ Time Frame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 signs and symptoms of cardiovascular disease
  • Other criteria will be discussed in detail with potential subjects by site Investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339064


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85013
United States, California
Loma Linda, California, United States, 92354
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90095
United States, Colorado
Aurora, Colorado, United States, 80045
Englewood, Colorado, United States, 80113
United States, Florida
Boca Raton, Florida, United States, 33486
United States, Georgia
Atlanta, Georgia, United States, 30329
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Michigan
West Bloomfield, Michigan, United States, 48322
United States, New York
Albany, New York, United States, 12208
United States, Ohio
Cincinnati, Ohio, United States, 45219
United States, Oregon
Portland VA Medical Center
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
USWM, LLC (dba US WorldMeds)
Investigators
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Study Director: Najeebah Abdul-Musawir, MD, MBA Supernus Pharmaceuticals, Inc.
More Information
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Responsible Party: USWM, LLC (dba US WorldMeds)
ClinicalTrials.gov Identifier: NCT02339064    
Other Study ID Numbers: USWM-AP2-3000
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Keywords provided by USWM, LLC (dba US WorldMeds):
Parkinson's disease,
apomorphine
Apokyn
dopamine agonist
levodopa
advanced
PD
carbidopa
 pramipexole
ropinirole
rotigotine
MAO-B inhibitors
COMT inhibitors
off
dyskinesia
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Apomorphine
 Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action