Infusion of Apomorphine: Long-term Safety Study | NCT02339064

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 31, 2014

First Submission Date that Met QC Criteria

Jan 9, 2015

First Posted Date

Jan 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 10, 2020

Certification/Extension First Submitted that Passed QC Review

Jan 10, 2020

Certification/Extension First Posted Date

Jan 14, 2020Actual

Last Update Submitted Date

Jun 18, 2025

Last Update Posted Date

Jun 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apomorphine infusion	Experimental	Continuous subcutaneous apomorphine infusion	Drug: apomorphine infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
apomorphine infusion	Drug	Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device	Apomorphine infusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent of daily "off" time during the waking day		Baseline Visit to Week 12

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona	85013	United States

ID	Term
D010300	Parkinson Disease
D020820	Dyskinesias

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms