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

June 18, 2025 updated by: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
    • California
      • Loma Linda, California, United States, 92354
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90033
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80113
    • Florida
      • Boca Raton, Florida, United States, 33486
    • Georgia
      • Atlanta, Georgia, United States, 30329
      • Augusta, Georgia, United States, 30912
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60612
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
    • New York
      • Albany, New York, United States, 12208
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Washington
      • Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of daily "off" time during the waking day
Time Frame: Baseline Visit to Week 12
Baseline Visit to Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent daily "on" time without troublesome dyskinesias during waking day
Time Frame: Baseline Visit to Week 12
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
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
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
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
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
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
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
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
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
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
Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Investigators

  • Study Director: Gianpiera Ceresoli-Borroni, PhD, Supernus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

December 1, 2018

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 31, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimated)

January 15, 2015

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 18, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USWM-AP2-3000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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