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Active, Not Recruiting

NCT Number: NCT02339064

Infusion of Apomorphine: Long-term Safety Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

IDIOPATHIC PARKINSON'S DISEASE Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

apomorphine infusion

Drug

Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device

Primary outcomes

  1. Percent of daily "off" time during the waking day

    Time frame: Baseline Visit to Week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: INFUS-ON

Important dates

Study start
2015
Primary completion
2018
Study completion
2025
First posted
Jan 15, 2015
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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