Ireland
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Active, not recruiting Phase 3

Infusion of Apomorphine: Long-term Safety Study

NCT02339064 · tracked via the Priya Life Science USA tracker
Sponsor
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Phase
Phase 3
Started
2015-02
Last updated
2025-06-19

Condition(s) studied

Idiopathic Parkinson's Disease

Investigational drug(s) / intervention(s)

apomorphine infusion

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

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percent of daily "off" time during the waking day — Baseline Visit to Week 12

Trial sites (18)

FacilityCityRegionStatus
— Phoenix Arizona
— Loma Linda California
— Los Angeles California
— Los Angeles California
— Aurora Colorado
— Englewood Colorado
— Boca Raton Florida
— Atlanta Georgia
— Augusta Georgia
— Chicago Illinois
— Chicago Illinois
— Kansas City Kansas
— West Bloomfield Michigan
— Albany New York
— Cincinnati Ohio
Portland VA Medical Center Portland Oregon
— Philadelphia Pennsylvania
— Kirkland Washington
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02339064 on ClinicalTrials.gov ↗ ← All trials in the USA