Trial Outcomes & Findings for Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN® (NCT NCT02549573)

NCT ID: NCT02549573

Last Updated: 2023-09-01

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline and after week 6
• Results posted on: 2023-09-01

Participant Flow

Participant milestones

Measure	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. 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 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. Physical Therapy: All subjects will participate in a standardized PT intervention
Overall Study STARTED	6	7
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	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. 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 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. Physical Therapy: All subjects will participate in a standardized PT intervention
Overall Study Withdrawal by Subject	0	2
Overall Study Protocol Violation	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=7 Participants 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 n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and after week 6

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

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

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Activities-specific Balance Confidence (ABC) Scale	3.1 percent change Standard Deviation 8.70	15.2 percent change Standard Deviation 17.72

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)	-4.2 units on a scale Standard Deviation 10.01	-0.8 units on a scale Standard Deviation 7.27

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Modified Physical Performance Test (M-PPT)	3.8 units on a scale Standard Deviation 2.93	5.8 units on a scale Standard Deviation 4.11

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Timed-Up-and-Go (TUG) Test	-4.0 seconds Standard Deviation 3.08	0.1 seconds Standard Deviation 2.13

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in 6-Minute Walk Test (6MWT)	238.7 feet Standard Deviation 191.88	315.3 feet Standard Deviation 317.36

SECONDARY outcome

Timeframe: Baseline and after week 6

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

The MoCA is a validated, 30-point test (sum of the 6 domains), with scores ranging from 0 (worst) to 30 (best). The test is designed to assess several cognitive domains, including visuospatial abilities (5 points), animal 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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Montreal Cognitive Assessment (MoCA)	0.3 units on a scale Standard Deviation 1.21	-0.3 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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).

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in MDS-UPDRS Part I A	-0.3 units on a scale Standard Deviation 1.21	-2.3 units on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: After week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) Minimally Improved	2 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) Much Improved	3 Participants	2 Participants
Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) Very Much Improved	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in MDS-UPDRS Part II	-0.7 units on a scale Standard Deviation 3.01	-1.3 units on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in MDS-UPDRS Part IV	1.2 units on a scale Standard Deviation 1.47	0 units on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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).

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in MDS-UPDRS Part I B	1.0 units on a scale Standard Deviation 4.43	-0.8 units on a scale Standard Deviation 3.50

SECONDARY outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Clinical Global Impression of Severity (CGI-S)	-0.7 units on a scale Standard Deviation 0.82	0 units on a scale Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39)	4.8 units on a scale Standard Deviation 5.71	-8.8 units on a scale Standard Deviation 8.88

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

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

PFS-16 is a subject-reported scale evaluating the physical effects of fatigue and its impact on daily function, with a minimum score of 16 and a maximum score of 80. Ratings are based on feelings and experiences over the prior 2 weeks, with scoring ranging from 1 (strongly disagree) to 5 (strongly agree), where lower scores are associated with less fatigue and higher scores are associated with greater fatigue.

A negative change from baseline represents an improvement in the physical effects of fatigue and the impact on daily function. .

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Parkinson's Fatigue Scale (PFS-16)	-3.5 units on a scale Standard Deviation 10.27	-8.3 units on a scale Standard Deviation 7.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety	0.3 units on a scale Standard Deviation 2.73	1.0 units on a scale Standard Deviation 2.83

OTHER_PRE_SPECIFIED outcome

Timeframe: After week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) Minimally Improved	1 Participants	3 Participants
Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) Much Improved	2 Participants	1 Participants
Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) Data Not Collected	1 Participants	0 Participants
Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) No Change	1 Participants	0 Participants
Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) Very Much Improved	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

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

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

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week	0 number of falls reported Standard Deviation 0	-1.0 number of falls reported Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

Population: 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.

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=5 Participants 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 Physical Therapy n=4 Participants 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
Change From Baseline in Patient Global Impression of Severity (PGI-S)	0.4 units on a scale Standard Deviation 1.14	0 units on a scale Standard Deviation 0.82

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after week 6

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

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.

Outcome measures

Measure	Apokyn Treatment Before Physical Therapy n=6 Participants 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 Physical Therapy n=4 Participants 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
Hospital Anxiety and Depression Scale - Change From Baseline in Depression	-0.5 units on a scale Standard Deviation 2.88	-1.0 units on a scale Standard Deviation 2.94

Adverse Events

Apokyn Treatment Before Physical Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Apokyn Treatment Withheld Before Physical Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Apokyn Treatment Before Physical Therapy n=6 participants at risk 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 Physical Therapy n=7 participants at risk 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
Vascular disorders Accelerated Hypertension	16.7% 1/6 • Number of events 1	0.00% 0/7

Other adverse events

Adverse event data not reported

Additional Information

Regulatory Affairs Specialist

US WorldMeds

Email: regulatoryaffairs@usworldmeds.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER