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

Primary Purpose

Idiopathic Parkinson's Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
apomorphine infusion
Sponsored by
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson's disease,, apomorphine, Apokyn, dopamine agonist, levodopa, advanced, PD, carbidopa, pramipexole, ropinirole, rotigotine, MAO-B inhibitors, COMT inhibitors, off, dyskinesia

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portland VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apomorphine infusion

Arm Description

Continuous subcutaneous apomorphine infusion

Outcomes

Primary Outcome Measures

Percent of daily "off" time during the waking day

Secondary Outcome Measures

Percent daily "on" time without troublesome dyskinesias during waking day
Percent of daily "off" time during the waking day
Percent of daily "on" time without troublesome dyskinesias during the waking day
Percent of daily "on" time without dyskinesias
Unified Parkinson's Disease Rating Scale - Motor Score
Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale
Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale
Parkinson's Disease Questionnaire
United Parkinson's Disease Rating Scale - Activities of Daily Living Score
Proportion of responders
Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry

Full Information

First Posted
March 31, 2014
Last Updated
August 8, 2023
Sponsor
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02339064
Brief Title
Infusion of Apomorphine: Long-term Safety Study
Acronym
INFUS-ON
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 Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Parkinson's disease,, apomorphine, Apokyn, dopamine agonist, levodopa, advanced, PD, carbidopa, pramipexole, ropinirole, rotigotine, MAO-B inhibitors, COMT inhibitors, off, dyskinesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apomorphine infusion
Arm Type
Experimental
Arm Description
Continuous subcutaneous apomorphine infusion
Intervention Type
Drug
Intervention Name(s)
apomorphine infusion
Intervention Description
Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
Primary Outcome Measure Information:
Title
Percent of daily "off" time during the waking day
Time Frame
Baseline Visit to Week 12
Secondary Outcome Measure Information:
Title
Percent daily "on" time without troublesome dyskinesias during waking day
Time Frame
Baseline Visit to Week 12
Title
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
Title
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
Title
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
Title
Unified Parkinson's Disease Rating Scale - Motor Score
Time Frame
Baseline Visit to Week 12
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpiera Ceresoli-Borroni, PhD
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

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Infusion of Apomorphine: Long-term Safety Study

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