Clinical trial NCT02339064: Infusion of Apomorphine: Long-term Safety Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Keywords: Parkinson's disease,
apomorphine
Apokyn
dopamine agonist
levodopa
advanced
PD
carbidopa
pramipexole
ropinirole
rotigotine
MAO-B inhibitors
COMT inhibitors
off
dyskinesia
Lead sponsor: Supernus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-15
Enrollment: 99
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Percent of daily "off" time during the waking day
timeFrame: Baseline Visit to Week 12
Secondary outcomes:
measure: Percent daily "on" time without troublesome dyskinesias during waking day
timeFrame: Baseline Visit to Week 12
measure: Percent of daily "off" time during the waking day
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Percent of daily "on" time without troublesome dyskinesias during the waking day
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Percent of daily "on" time without dyskinesias
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Unified Parkinson's Disease Rating Scale - Motor Score
timeFrame: Baseline Visit to Week 12
measure: Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Parkinson's Disease Questionnaire
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: United Parkinson's Disease Rating Scale - Activities of Daily Living Score
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Proportion of responders
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
measure: Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry
timeFrame: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Loma Linda
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Boca Raton
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Kansas City
country: United States
state: Kansas
city: West Bloomfield
country: United States
state: Michigan
city: Albany
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Kirkland
country: United States
state: Washington
Study officials:
affiliation: Supernus Pharmaceuticals, Inc.
name: Gianpiera Ceresoli-Borroni, PhD
role: STUDY_DIRECTOR
References: