Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®
Condition: Parkinson's Disease; Motor Symptoms
MeSH terms: Parkinson Disease
Intervention: APOKYN; Physical Therapy
Intervention description: Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.; All subjects will participate in a standardized PT intervention
Intervention MeSH terms: Apomorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Motor Symptoms; Parkinson's disease; Apokyn; Apomorphine; PD

Summary:

      To determine if PT intervention will be improved while in the "on" motor state vs. the
      "end-of-dose-off" motor state during the PT Intervention Visit in subjects with PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and sign an Investigational Review Board (IRB)-approved written
             informed consent and privacy language (e.g., Health Insurance Portability and
             Accountability Act (HIPAA) authorization) as per national regulations before any
             study-related procedures are performed.

          -  Must have a diagnosis of idiopathic PD.

          -  Adult male or female 18 to 78 years of age, inclusive.

          -  Currently using APOKYN, per the Package Insert, for at least 4 weeks before Baseline
             Assessment Visit(s).

          -  Currently using carbidopa/levodopa therapy at a steady maintenance dose, representing
             a stable treatment regimen in the opinion of the Investigator, for at least 4 weeks
             before Baseline Assessment Visit(s).

          -  Able to walk 50 feet independently (cane permissible) at the Baseline Assessment
             Visit.

          -  Meet all of the following parameters to demonstrate an optimal response to APOKYN at
             the APOKYN Response Verification Visit: must be "on" in the opinion of the subject and
             investigator within 20 minutes after the APOKYN injection; and have a motor state
             improvement of >25% per the Movement Disorder Society (MDS)-UPDRS Motor Score (Part
             III), within 20 minutes after the APOKYN injection, as compared to pre-injection.

          -  Willing and able to comply with scheduled visits, treatment plan, other study-related
             procedures, and have available caregiver to provide transportation to clinic visits as
             needed.

        Exclusion Criteria:

          -  Received PT targeting Parkinson's disease within 6 months before Baseline Assessment
             Visit(s).

          -  Received any investigational (i.e., unapproved) drug product within the last 30 days
             (or 5 half-lives, whichever is longer) before the Baseline Assessment Visit(s).

          -  Currently taking, or likely to need to take at any time during the course of the
             study, any 5HT3 antagonist (i.e., ondansetron, granisetron, dolasetron, palonosetron,
             alosetron).

          -  Currently on or likely to transition to the DUOPA (carbidopa and levodopa enteral
             suspension) during the course of the study.

          -  Has orthostatic hypotension (defined as >30 mmHg decrease in systolic blood pressure
             or >15 mmHg decrease in diastolic blood pressure within 2 minutes of standing from a
             supine position) at the Baseline Assessment Visit(s), or within 20 minutes following
             APOKYN injection at the APOKYN Verification Visit.

          -  Has a score of 24 or higher on the Modified Physical Performance Test (M-PPT).

          -  Has a score of 80% or higher on the Activities-specific Balance Confidence Scale
             (ABC).

          -  Has any significant current medical disorder, physical, or mental condition that
             would, in the Investigator's opinion, represent a hazard to the subject or prevent the
             subject from completing the study.

          -  Subjects with dementia, in the Investigator's opinion, or subjects with a Montreal
             Cognitive Assessment (MoCA) <18.