| Primary | Change From Baseline in Activities-specific Balance Confidence (ABC) Scale | Scale from 0 to 100% where an increase in percent represents an improvement in balance confidence. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | percent change | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.1± 8.70
- OG00115.2± 17.72
|
|
| |
| Secondary | Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in Modified Physical Performance Test (M-PPT) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in Timed-Up-and-Go (TUG) Test | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | seconds | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in 6-Minute Walk Test (6MWT) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | feet | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in Montreal Cognitive Assessment (MoCA) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Apokyn Treatment Withheld Before Physical Therapy |
|
| Secondary | Change From Baseline in MDS-UPDRS Part I A | 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). | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Count of Participants | | Participants | | After week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Apokyn Treatment Withheld Before Physical Therapy | |
|
| Other Pre-specified | Change From Baseline in Parkinson's Fatigue Scale (PFS-16) | 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. . | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Apokyn Treatment Withheld Before Physical Therapy |
|
| Other Pre-specified | Hospital Anxiety and Depression Scale - Change From Baseline in Anxiety | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Number of Participants in Each Category of Patient Global Impression of Change (PGI-C) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Count of Participants | | Participants | | After week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Change From Baseline in Number of Falls as Reported by the Subject in the Past 1 Week | Subject reported number of falls. A negative change from baseline represents a decrease in the frequency of falls. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | number of falls reported | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in MDS-UPDRS Part II | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in MDS-UPDRS Part IV | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in MDS-UPDRS Part I B | 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). | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Change From Baseline in Patient Global Impression of Severity (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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 |
|
| Other Pre-specified | Hospital Anxiety and Depression Scale - Change From Baseline in Depression | 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. | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and after week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | Apokyn Treatment Withheld Before Physical Therapy | |
|