Infusion of Apomorphine: Long-term Safety Study

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Apomorphine infusion
    • Continuous subcutaneous apomorphine infusion

Clinical Trial Outcome Measures

Primary Measures

  • Percent of daily “off” time during the waking day
    • Time Frame: Baseline Visit to Week 12

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • US WorldMeds LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Najeebah Abdul-Musawir, MD, MBA, Study Director, Supernus Pharmaceuticals, Inc.

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