Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02549573
• Date of registration: 09/09/2015
• Prospective Registration: Yes
• Primary sponsor: US WorldMeds LLC
• Public title: Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN® PERFORM
• Scientific title: Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an "On" Versus "End-of-Dose-Off" Motor State
• Date of first enrolment: January 2016
• Target sample size: 13
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02549573
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Mark Pirner, MD
• Affiliation: US WorldMeds

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 78 Years
Gender: All

Health Condition(s) or Problem(s) studied

Motor Symptoms

Parkinson's Disease

Intervention(s)

Behavioral: Physical Therapy

Drug: APOKYN

Primary Outcome(s)

Activities-specific Balance Confidence (ABC) Scale total percent score [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Secondary Outcome(s)

Clinical Global Impression of Severity (CGI-S) and Change (CGI-C) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

MDS-UPDRS (Parts I, II, and IV) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Modified Physical Performance Test (M-PPT) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

6-Minute Walk Test (6MWT) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Montreal Cognitive Assessment (MoCA) [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Timed-Up-and-Go (TUG) Test [Time Frame: Change from baseline assessment (week 1) to end-of-study assessment (week 10)]

Secondary ID(s)

USWM-AP1-4002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors