Infusion of Apomorphine: Long-term Safety Study

Phase 3

Active, not recruiting

• Conditions: Idiopathic Parkinson's Disease
• Interventions: Drug: apomorphine infusion

• Registration Number: NCT02339064
• Lead Sponsor: MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2014-03-31
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-15
• Study Start: 2015-02
• Primary Completion: 2018-12
• Disposition First Submitted: 2020-01-10
• Disposition First Submitted QC: 2020-01-10
• Disposition First Posted: 2020-01-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apomorphine infusion	apomorphine infusion	Continuous subcutaneous apomorphine infusion

Primary Outcome Measures

Name	Time	Method
Percent of daily "off" time during the waking day	Baseline Visit to Week 12

Secondary Outcome Measures

Name	Time	Method
Percent daily "on" time without troublesome dyskinesias during waking day	Baseline Visit to Week 12
Percent of daily "off" time during the waking day	Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Parkinson's Disease Questionnaire	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	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	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	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	Baseline Visit to Week 12
Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale	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	Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Proportion of responders	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	Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

Trial Locations

Locations (1)

Portland VA Medical Center; 🇺🇸 Portland, Oregon, United States