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Trial record 2 of 7 for:    apokyn | Recruiting Studies

Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by US WorldMeds LLC
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC
ClinicalTrials.gov Identifier:
NCT02339064
First received: March 31, 2014
Last updated: July 31, 2017
Last verified: July 2017
  Purpose
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 Intervention Phase
Idiopathic Parkinson's Disease Drug: apomorphine infusion Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by US WorldMeds LLC:

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

Secondary Outcome Measures:
  • Percent daily "on" time without troublesome dyskinesias during waking day [ Time Frame: Baseline Visit to Week 12 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Unified Parkinson's Disease Rating Scale - Motor Score [ Time Frame: Baseline Visit to Week 12 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 100
Study Start Date: February 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02339064

Contacts
Contact: Jenny Kersey jkersey@usworldmeds.com

Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States, 85013
United States, California
Recruiting
Loma Linda, California, United States, 92354
Recruiting
Los Angeles, California, United States, 90033
Recruiting
Los Angeles, California, United States, 90095
United States, Colorado
Recruiting
Aurora, Colorado, United States, 80045
Recruiting
Englewood, Colorado, United States, 80113
United States, Florida
Recruiting
Boca Raton, Florida, United States, 33486
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30329
Recruiting
Augusta, Georgia, United States, 30912
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
Recruiting
Chicago, Illinois, United States, 60612
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
United States, Michigan
Recruiting
West Bloomfield Township, Michigan, United States, 48322
United States, New York
Terminated
Albany, New York, United States, 12208
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Recruiting
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
US WorldMeds LLC
Investigators
Study Director: Cynthia Rask, MD US WorldMeds LLC
  More Information

Responsible Party: US WorldMeds LLC
ClinicalTrials.gov Identifier: NCT02339064     History of Changes
Other Study ID Numbers: USWM-AP2-3000
Study First Received: March 31, 2014
Last Updated: July 31, 2017

Keywords provided by US WorldMeds LLC:
apomorphine
Apokyn
Parkinson's disease,
dopamine agonist
levodopa
advanced
PD
carbidopa
pramipexole
ropinirole
rotigotine
MAO-B inhibitors
COMT inhibitors
off
dyskinesia

Additional relevant MeSH terms:
Apomorphine
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Emetics
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017