Trial · NCT02549573
Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®
NCT02549573, Phase 4, Terminated, MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals; results first posted 2018-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®. Trials, record NCT02549573. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02549573
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®
- NCT number
- NCT02549573
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 13 participants, actual
- Lead sponsor
- MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
- Conditions
- Parkinson's Disease, Motor Symptoms
- Interventions
- APOKYN, Physical Therapy
- First posted
- 2015-09-15
- Last updated
- 2023-09-01
- Results first posted
- 2018-01-12
- Limitations and 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.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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), 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Activities-specific Balance Confidence (ABC) Scale | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | percent change | MEAN |
| SECONDARY | Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Modified Physical Performance Test (M-PPT) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Timed-Up-and-Go (TUG) Test | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | seconds | MEAN |
| SECONDARY | Change From Baseline in 6-Minute Walk Test (6MWT) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | feet | MEAN |
| SECONDARY | Change From Baseline in Montreal Cognitive Assessment (MoCA) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in MDS-UPDRS Part I A | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
| SECONDARY | Number of Participants in Each Category of Clinical Global Impression of Change (CGI-C) | After week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Parkinson's Fatigue Scale (PFS-16) | Baseline and after week 6 | The per protocol population included all subjects who completed at least 12 of the 18 physical therapy intervention visits within 6 weeks. | units on a scale | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Activities-specific Balance Confidence (ABC) Scale | Apokyn Treatment Before Physical Therapy | 3.1 | Standard Deviation 8.70 | percent change | |
| Change From Baseline in Activities-specific Balance Confidence (ABC) Scale | Apokyn Treatment Withheld Before Physical Therapy | 15.2 | Standard Deviation 17.72 | percent change | |
| Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) | Apokyn Treatment Before Physical Therapy | -4.2 | Standard Deviation 10.01 | units on a scale | |
| Change From Baseline in Movement Disorder Societies Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) | Apokyn Treatment Withheld Before Physical Therapy | -0.8 | Standard Deviation 7.27 | units on a scale | |
| Change From Baseline in Modified Physical Performance Test (M-PPT) | Apokyn Treatment Before Physical Therapy | 3.8 | Standard Deviation 2.93 | units on a scale | |
| Change From Baseline in Modified Physical Performance Test (M-PPT) | Apokyn Treatment Withheld Before Physical Therapy | 5.8 | Standard Deviation 4.11 | units on a scale | |
| Change From Baseline in Timed-Up-and-Go (TUG) Test | Apokyn Treatment Before Physical Therapy | -4.0 | Standard Deviation 3.08 | seconds | |
| Change From Baseline in Timed-Up-and-Go (TUG) Test | Apokyn Treatment Withheld Before Physical Therapy | 0.1 | Standard Deviation 2.13 | seconds | |
| Change From Baseline in 6-Minute Walk Test (6MWT) | Apokyn Treatment Before Physical Therapy | 238.7 | Standard Deviation 191.88 | feet | |
| Change From Baseline in 6-Minute Walk Test (6MWT) | Apokyn Treatment Withheld Before Physical Therapy | 315.3 | Standard Deviation 317.36 | feet |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Apokyn Treatment Before Physical Therapy | 6 | |
| Overall Study | STARTED | Apokyn Treatment Withheld Before Physical Therapy | 7 | |
| Overall Study | COMPLETED | Apokyn Treatment Before Physical Therapy | 6 | |
| Overall Study | COMPLETED | Apokyn Treatment Withheld Before Physical Therapy | 4 | |
| Overall Study | NOT COMPLETED | Apokyn Treatment Before Physical Therapy | 0 | |
| Overall Study | NOT COMPLETED | Apokyn Treatment Withheld Before Physical Therapy | 3 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Accelerated Hypertension | Vascular disorders | Apokyn Treatment Before Physical Therapy | 1 | 6 | 1 |
| serious | Accelerated Hypertension | Vascular disorders | Apokyn Treatment Withheld Before Physical Therapy | 0 | 7 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Apokyn Treatment Before Physical Therapy | ||
| Total, all-cause mortality | Apokyn Treatment Withheld Before Physical Therapy | ||
| Total, other adverse events | Apokyn Treatment Before Physical Therapy | 0 | 6 |
| Total, other adverse events | Apokyn Treatment Withheld Before Physical Therapy | 0 | 7 |
| Total, serious adverse events | Apokyn Treatment Before Physical Therapy | 1 | 6 |
| Total, serious adverse events | Apokyn Treatment Withheld Before Physical Therapy | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Apokyn Treatment Before Physical Therapy vs Apokyn Treatment Withheld Before Physical Therapy: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Category Fluency | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02549573
GET https://conductscience.org/api/trials/v1/NCT02549573/results?page=2