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

• Sponsor: USWM, LLC (dba US WorldMeds) (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02549573
• Collaborator: (none)
• Enrollment: 13
• Locations: 12
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site: 1.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Motor Symptoms	Drug: APOKYN; Behavioral: Physical Therapy	Phase 4

Detailed Description

Multicenter, outpatient trial to evaluate PT outcomes in subjects diagnosed with PD and currently using APOKYN. Those subjects who satisfy all eligibility criteria will be randomized to 2 treatment groups:

1. "APO+" (APOKYN treatment before the PT Intervention Visit) and;

2. "APO-" (APOKYN treatment withheld before the PT Intervention Visit).

The study will have:

• Baseline Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic

• APOKYN Response Verification Visit - 1 day

• PT Intervention Visits - for 6 weeks

• End-of-study Assessment Visit(s) - 1 day at Investigator's clinic and PT clinic All subjects will participate in a standardized PT intervention. In both treatment groups, ALL subjects will arrive for the PT Intervention Visit in an "end-of-dose-off" motor state. The "end-of-dose-off" motor state will be achieved by the subject withholding his/her carbidopa/levodopa dose and APOKYN dose for at least 3 hours before the PT Intervention Visit. It is hypothesized that the outcome of PT will be improved when subjects are in the "on" motor state during PT Intervention visits compared with being in the "end-of-dose-off" motor state during PT Intervention visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official 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
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Apokyn treatment before physical therapy APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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.	Drug: APOKYN; 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.; Other Names: Apomorphine APO ; Behavioral: Physical Therapy; All subjects will participate in a standardized PT intervention; Other Names: PT
Other: Apokyn treatment withheld before physical therapy APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation.	Behavioral: Physical Therapy; All subjects will participate in a standardized PT intervention; Other Names: PT

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Activities-specific Balance Confidence (ABC) Scale [Baseline and after week 6]

   Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.

Secondary Outcome Measures

1. Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) [Baseline and after week 6]

   MDS-UPDRS Part III is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 72 (worst score possible). A negative change from baseline represents an improvement in motor function.

2. Change From Baseline in Modified Physical Performance Test (M-PPT) [Baseline and after week 6]

   Investigator scale assessing 9 domains of physical functioning where total scores range from 0 to 28 with higher scores indicating better physical performance. A positive change from baseline represents an improvement in physical performance.

3. Change From Baseline in Timed-Up-and-Go (TUG) Test [Baseline and after week 6]

   Test captures the amount of time for a subject to get up from an arm chair, walk 3 meters, turn around, walk back to chair, and sit. A negative change from baseline represents an improvement of physical function.

4. Change From Baseline in 6-Minute Walk Test (6MWT) [Baseline and after week 6]

   Objective performance based measure of functional exercise capacity that measures the distance a subject can cover on a 30 meter flat walking area over 6 minutes. A positive change from baseline represents an improvement in the distance walked (ft) in 6 minutes.

5. Change From Baseline in Montreal Cognitive Assessment (MoCA) [Baseline and after week 6]

   The MoCA is a validated, 30-point test (sum of the 6 domains) designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). Total MoCA scores higher than 26 indicate normal cognitive function. A positive change from baseline represents an improvement in cognitive function.

6. Change From Baseline in MDS-UPDRS Part I A [Baseline and after week 6]

   MDS-UPDRS Part I A is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (investigator rated).

7. Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) [After week 6]

   Investigator's impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from very much improved to very much worse.

8. Change From Baseline in MDS-UPDRS Part II [Baseline and after week 6]

   MDS-UPDRS Part II is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 52 (worst score possible). A negative change from baseline represents an improvement in motor experience of daily living.

9. Change From Baseline in MDS-UPDRS Part IV [Baseline and after week 6]

   MDS-UPDRS Part IV is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents fewer motor complications.

10. Change From Baseline in MDS-UPDRS Part I B [Baseline and after week 6]

    MDS-UPDRS Part I B is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 28 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (subject rated).

11. Change From Baseline in Clinical Global Impression of Severity (CGI-S) [Baseline and after week 6]

    Investigator's impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.

Other Outcome Measures

1. Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) [Baseline and after week 6]

   PDQ-39 is a scale measuring subject reported aspects of functioning and well-being. Each of the 39 items is rated using a 5-points Likert scale, with 0 for never having difficulties/problems and 4 for all always having difficulties/problems. The total score is the sum of the 39 items, with a minimum score of 0 and a maximum score of 156. A negative change from baseline represents an improvement in functioning and well-being.

2. Change From Baseline in Parkinson's Fatigue Scale (PFS-16) [Baseline and after week 6]

   PFS-16 is a subject reported scale evaluating physical effects of fatigue and the impact on daily function, with a minimum score of 16 and a maximum score of 80. A negative change from baseline represents an improvement in physical effects of fatigue and the impact on daily function.

3. Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety [Baseline and after week 6]

   The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in anxiety.

4. Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) [After week 6]

   Self reported (caregiver, if applicable) impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from much improved to very much worse.

5. Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week [Baseline and after week 6]

   Subject reported number of falls. A negative change from baseline represents a decrease in the frequency of falls.

6. Change From Baseline in Patient Global Impression of Severity (PGI-S) [Baseline and after week 6]

   Self reported (caregiver, if applicable) impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.

7. Hospital Anxiety and Depression Scale - Change From Baseline in Depression [Baseline and after week 6]

   The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in depression.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States	85013
2		Scottsdale	Arizona	United States	85258
3		Loma Linda	California	United States	92354
4		Sunnyvale	California	United States	94085
5		Orlando	Florida	United States	32803
6		Foxboro	Massachusetts	United States	02035
7		Cleveland	Ohio	United States	44106
8		Tulsa	Oklahoma	United States	74136
9		Hershey	Pennsylvania	United States	17033
10		Austin	Texas	United States	78746
11		Kirkland	Washington	United States	98034
12		Tacoma	Washington	United States	98409

Sponsors and Collaborators

• USWM, LLC (dba US WorldMeds)

Investigators

• Study Director: Mark Pirner, MD, US WorldMeds

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: USWM, LLC (dba US WorldMeds)
• ClinicalTrials.gov Identifier: NCT02549573
• Other Study ID Numbers: USWM-AP1-4002
• First Posted: Sep 15, 2015
• Last Update Posted: Jan 12, 2018
• Last Verified: Dec 1, 2017

• Keywords provided by USWM, LLC (dba US WorldMeds): Motor Symptoms; Parkinson's disease; Apokyn; Apomorphine; PD
• Additional relevant MeSH terms: Parkinson Disease; Apomorphine

Study Results

Participant Flow

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Period Title: Overall Study
STARTED	6	7
COMPLETED	6	4
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy	Total
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention	Total of all reporting groups
Overall Participants	6	7	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 33.3%	3 42.9%	5 38.5%
>=65 years	4 66.7%	4 57.1%	8 61.5%
Sex: Female, Male (Count of Participants)
Female	0 0%	2 28.6%	2 15.4%
Male	6 100%	5 71.4%	11 84.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 14.3%	1 7.7%
Not Hispanic or Latino	6 100%	6 85.7%	12 92.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	6 100%	6 85.7%	12 92.3%
Hispanic	0 0%	1 14.3%	1 7.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Activities-specific Balance Confidence (ABC) Scale
Description	Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [percent change]	3.1 (8.70)	15.2 (17.72)

2. Secondary Outcome

Title	Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)
Description	MDS-UPDRS Part III is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 72 (worst score possible). A negative change from baseline represents an improvement in motor function.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-4.2 (10.01)	-0.8 (7.27)

3. Secondary Outcome

Title	Change From Baseline in Modified Physical Performance Test (M-PPT)
Description	Investigator scale assessing 9 domains of physical functioning where total scores range from 0 to 28 with higher scores indicating better physical performance. A positive change from baseline represents an improvement in physical performance.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	3.8 (2.93)	5.8 (4.11)

4. Secondary Outcome

Title	Change From Baseline in Timed-Up-and-Go (TUG) Test
Description	Test captures the amount of time for a subject to get up from an arm chair, walk 3 meters, turn around, walk back to chair, and sit. A negative change from baseline represents an improvement of physical function.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [seconds]	-4.0 (3.08)	0.1 (2.13)

5. Secondary Outcome

Title	Change From Baseline in 6-Minute Walk Test (6MWT)
Description	Objective performance based measure of functional exercise capacity that measures the distance a subject can cover on a 30 meter flat walking area over 6 minutes. A positive change from baseline represents an improvement in the distance walked (ft) in 6 minutes.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [feet]	238.7 (191.88)	315.3 (317.36)

6. Secondary Outcome

Title	Change From Baseline in Montreal Cognitive Assessment (MoCA)
Description	The MoCA is a validated, 30-point test (sum of the 6 domains) designed to assess several cognitive domains, including visuospatial abilities (5 points), naming (3 points), attention (6 points), language (3 points), abstraction (2 points), delayed recall (5 points), and orientation to time and place (6 points). Total MoCA scores higher than 26 indicate normal cognitive function. A positive change from baseline represents an improvement in cognitive function.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	0.3 (1.21)	-0.3 (0.96)

7. Secondary Outcome

Title	Change From Baseline in MDS-UPDRS Part I A
Description	MDS-UPDRS Part I A is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (investigator rated).
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-0.3 (1.21)	-2.3 (2.50)

8. Secondary Outcome

Title	Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C)
Description	Investigator's impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from very much improved to very much worse.
Time Frame	After week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Minimally Improved	2 33.3%	2 28.6%
Much Improved	3 50%	2 28.6%
Very Much Improved	1 16.7%	0 0%

9. Other Pre-specified Outcome

Title	Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39)
Description	PDQ-39 is a scale measuring subject reported aspects of functioning and well-being. Each of the 39 items is rated using a 5-points Likert scale, with 0 for never having difficulties/problems and 4 for all always having difficulties/problems. The total score is the sum of the 39 items, with a minimum score of 0 and a maximum score of 156. A negative change from baseline represents an improvement in functioning and well-being.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	4.8 (5.71)	-8.8 (8.88)

10. Other Pre-specified Outcome

Title	Change From Baseline in Parkinson's Fatigue Scale (PFS-16)
Description	PFS-16 is a subject reported scale evaluating physical effects of fatigue and the impact on daily function, with a minimum score of 16 and a maximum score of 80. A negative change from baseline represents an improvement in physical effects of fatigue and the impact on daily function.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-3.5 (10.27)	-8.3 (7.72)

11. Other Pre-specified Outcome

Title	Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety
Description	The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in anxiety.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	0.3 (2.73)	1.0 (2.83)

12. Other Pre-specified Outcome

Title	Number of Participants in Each Category of Patient Global Impression of Change (PGI-C)
Description	Self reported (caregiver, if applicable) impression of change in the subject's symptoms from baseline assessment visit to end of study assessment, on a 7-point scale ranging from much improved to very much worse.
Time Frame	After week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
No Change	1 16.7%	0 0%
Minimally Improved	1 16.7%	3 42.9%
Much Improved	2 33.3%	1 14.3%
Very Much Improved	1 16.7%	0 0%
Data Not Collected	1 16.7%	0 0%

13. Other Pre-specified Outcome

Title	Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week
Description	Subject reported number of falls. A negative change from baseline represents a decrease in the frequency of falls.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [number of falls reported]	0 (0)	-1.0 (0.82)

14. Secondary Outcome

Title	Change From Baseline in MDS-UPDRS Part II
Description	MDS-UPDRS Part II is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 52 (worst score possible). A negative change from baseline represents an improvement in motor experience of daily living.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-0.7 (3.01)	-1.3 (2.87)

15. Secondary Outcome

Title	Change From Baseline in MDS-UPDRS Part IV
Description	MDS-UPDRS Part IV is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 24 (worst score possible). A negative change from baseline represents fewer motor complications.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	1.2 (1.47)	0 (1.63)

16. Secondary Outcome

Title	Change From Baseline in MDS-UPDRS Part I B
Description	MDS-UPDRS Part I B is a sub-scale of MDS-UPDRS. Sub-scale scores range from 0 (best score possible) to 28 (worst score possible). A negative change from baseline represents an improvement in non-motor experiences of daily living (subject rated).
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	1.0 (4.43)	-0.8 (3.50)

17. Secondary Outcome

Title	Change From Baseline in Clinical Global Impression of Severity (CGI-S)
Description	Investigator's impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-0.7 (0.82)	0 (0.82)

18. Other Pre-specified Outcome

Title	Change From Baseline in Patient Global Impression of Severity (PGI-S)
Description	Self reported (caregiver, if applicable) impression of the severity of the subject's illness on a 7-point scale ranging from normal (1) to among the most extremely ill subjects (7). A negative change from baseline represents a decrease in the severity of the subject's illness.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. One subject in APO+ group did not have an end of study assessment for PGI-S.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	0.4 (1.14)	0 (0.82)

19. Other Pre-specified Outcome

Title	Hospital Anxiety and Depression Scale - Change From Baseline in Depression
Description	The Hospital Anxiety and Depression Scale is a 14-item Investigator-rated scale designed to determine levels of anxiety and depression in people with physical health problems. Seven items relate to anxiety and 7 items related to depression, where the scale ranges from 0 (best score possible) to 21 (worst score possible). A negative change from baseline represents a decrease in depression.
Time Frame	Baseline and after week 6

Outcome Measure Data

Analysis Population Description

The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks.

Arm/Group Title	Apokyn Treatment Before Physical Therapy	Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention	APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT. Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
Measure Participants	6	4
Mean (Standard Deviation) [units on a scale]	-0.5 (2.88)	-1.0 (2.94)

Adverse Events

Arm/Group Title	Apokyn Treatment Before Physical Therapy		Apokyn Treatment Withheld Before Physical Therapy
Arm/Group Description	APOKYN treatment before the PT Intervention Visit. Subjects in the "APO+" group will administer their 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. APOKYN: 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. Physical Therapy: All subjects will participate in a standardized PT intervention		APOKYN treatment withheld before the PT Intervention Visit. Subjects in the "APO-" group will not take carbidopa/levodopa and APOKYN for at least 3 hours before or during the PT Intervention Visit. No "rescue therapy" will be allowed during the PT Intervention Visit. If the PT Intervention Visit needs to be stopped early, the Physical Therapist will record this along with a reason for the discontinuation. Physical Therapy: All subjects will participate in a standardized PT intervention
All Cause Mortality
	Apokyn Treatment Before Physical Therapy		Apokyn Treatment Withheld Before Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Apokyn Treatment Before Physical Therapy		Apokyn Treatment Withheld Before Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		0/7 (0%)
Vascular disorders
Accelerated Hypertension	1/6 (16.7%)	1	0/7 (0%)	0
Other (Not Including Serious) Adverse Events
	Apokyn Treatment Before Physical Therapy		Apokyn Treatment Withheld Before Physical Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)

Limitations/Caveats

Recruitment challenges (primarily due to standardized physical therapy requirements within sites) led to trial termination. The small number of subjects resulted in statistically unreliable results.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor has the first right, within 9 months following the later to occur 1) close out meeting or 2) Sponsor possessing all data, to publish the lead paper. Following the foregoing, Institution has the right to publish the results provided the Institution provides a Publications Committee, which includes the Sponsor, with a draft at least 30 days before submission. At Sponsor's request, Institution shall withhold publication for 45 days to allow filing of a patent application.