Infusion of Apomorphine: Long-term Safety Study

Idiopathic Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02339064
• Other study ID #: USWM-AP2-3000
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 2015
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: December 2024
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson's Disease
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of daily "off" time during the waking day		Baseline Visit to Week 12
Secondary	Percent daily "on" time without troublesome dyskinesias during waking day		Baseline Visit to Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Unified Parkinson's Disease Rating Scale - Motor Score		Baseline Visit to Week 12
Secondary	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
Secondary	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
Secondary	Parkinson's Disease Questionnaire		Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Secondary	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
Secondary	Proportion of responders		Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Secondary	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