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Trial record 2 of 13 for:    Apomorphine Infusion

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02339064
Recruitment Status : Active, not recruiting
First Posted : January 15, 2015
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
US WorldMeds LLC

Tracking Information
First Submitted Date  ICMJE March 31, 2014
First Posted Date  ICMJE January 15, 2015
Last Update Posted Date May 10, 2019
Study Start Date  ICMJE February 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
Percent of daily "off" time during the waking day [ Time Frame: Baseline Visit to Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2015)
occurrence of adverse events and adverse events of special interest [ Time Frame: screening through Week 52 ]
Change History Complete list of historical versions of study NCT02339064 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2015)
  • Daily "off" time [ Time Frame: baseline through Week 12 ]
  • Daily "on" time without troublesome dyskinesias [ Time Frame: baseline through Week 12 ]
  • Unified Parkinson's Disease Rating Scale - Motor Score [ Time Frame: baseline through Week 12 ]
  • Clinical Global Impression of Severity Scale [ Time Frame: baseline through Week 52 ]
  • Clinical Global Impression of Change Scale [ Time Frame: baseline through Week 52 ]
  • Patient Global Impression of Severity Scale [ Time Frame: baseline through end of study ]
  • Patient Global Impression of Change Scale [ Time Frame: baseline through Week 52 ]
  • Parkinson's Disease Questionnaire [ Time Frame: baseline through Week 52 ]
  • United Parkinson's Disease Rating Scale - Activities of Daily Living Score [ Time Frame: baseline through Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infusion of Apomorphine: Long-term Safety Study
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE Drug: apomorphine infusion
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Study Arms  ICMJE Experimental: Apomorphine infusion
Continuous subcutaneous apomorphine infusion
Intervention: Drug: apomorphine infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 2, 2018)
99
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2015)
60
Estimated Study Completion Date  ICMJE October 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02339064
Other Study ID Numbers  ICMJE USWM-AP2-3000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party US WorldMeds LLC
Study Sponsor  ICMJE US WorldMeds LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: W. Allan Alexander, MD US WorldMeds Employee
PRS Account US WorldMeds LLC
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP