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Idiopathic Parkinson's DiseasePhase 3INFUS-ONNCT02339064

Infusion of Apomorphine: Long-term Safety Study

A Phase 3 study testing apomorphine infusion in people with Idiopathic Parkinson's Disease, run by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals at 18 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Idiopathic Parkinson's Disease
What is being tested?
apomorphine infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
18 sitesUnited States
Study dates
Feb 2015to Dec 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Atlanta, Georgia, 30329

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Loma Linda, California, 92354

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90095

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85013

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Study site

    West Bloomfield, Michigan, 48322

Other trials in United States

About this 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

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.

Read the 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.

Being tested
apomorphine infusion
Keywords
Parkinson's disease,, apomorphine, Apokyn, dopamine agonist, levodopa, advanced, PD, carbidopa, pramipexole, ropinirole, rotigotine, MAO-B inhibitors, COMT inhibitors, off, dyskinesia
Medical subject headings
Parkinson Disease, Dyskinesias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • apomorphine infusionDrug

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

Study groups in NCT02339064
Study groupRoleWhat they receive
Apomorphine infusionExperimentalContinuous subcutaneous apomorphine infusion
Receives: Drug: apomorphine infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent of daily "off" time during the waking day

    Measured: Baseline Visit to Week 12

Secondary outcomes (11)

  1. Percent daily "on" time without troublesome dyskinesias during waking day

    Measured: Baseline Visit to Week 12

  2. Percent of daily "off" time during the waking day

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  3. Percent of daily "on" time without troublesome dyskinesias during the waking day

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  4. Percent of daily "on" time without dyskinesias

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  5. Unified Parkinson's Disease Rating Scale - Motor Score

    Measured: Baseline Visit to Week 12

  6. Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) Scale

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  7. Patient Global Impression of Severity (PGI-S) and Change (PGI-C) Scale

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  8. Parkinson's Disease Questionnaire

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  9. United Parkinson's Disease Rating Scale - Activities of Daily Living Score

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  10. Proportion of responders

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

  11. Frequency and total dose of average daily intermittent injection APOKYN for subjects on APOKYN treatment at study entry

    Measured: Baseline Visit to Treatment Weeks 2, 4, 8, 20, 28, 36, 44, and 52; and all Treatment Extension Period Visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2018
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02339064
Sponsor's protocol ID
USWM-AP2-3000
Acronym
INFUS-ON
Status last verified
Jun 2025
First submitted
31 Mar 2014
Last updated
19 Jun 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing apomorphine infusion in people with Idiopathic Parkinson's Disease, run by MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of daily "off" time during the waking day (time frame: Baseline Visit to Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02339064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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