Trial · NCT01536015
Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction
NCT01536015, Phase 3, Terminated, UCB Pharma; results first posted 2014-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction. Trials, record NCT01536015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01536015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal Dysfunction
- NCT number
- NCT01536015
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 25 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Advanced Parkinson's Disease
- Interventions
- Rotigotine, Placebo
- First posted
- 2012-02-20
- Last updated
- 2014-08-01
- Results first posted
- 2014-08-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Rotigotine Versus Placebo in the Absolute Time Spent "Off" From Baseline to the End of the 7-week Maintenance Period | Baseline to 10 weeks | Mean number of hours marked "off" during a 24-hour period. |
| Secondary | Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the "on" State From Baseline to the End of the 7-week Maintenance Period | Baseline to 10 weeks | The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III is an 18-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe). |
| Secondary | Change in Predictability of "Off" Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period | Baseline to 10 weeks | The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part IV is a 6-item scale with each single item of the scale ranging from 0 (normal) to 4 (severe). |
| Secondary | Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period | Baseline to 10 weeks | Gastrointestinal Neurodegenerative Scale (GIND) is an 18-item scale measuring gastrointestinal dysfunction with each single item of the scale ranging from 0 (never or not at all) to 5 (very severe). |
| Secondary | Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period | Baseline to 10 weeks | The Fatigue Severity Scale is a 9-item scale measuring the impact of fatigue on everyday functioning (e.g. "fatigue interferes with my work, each single item of the scale ranging from 1 (disagree) to 7 (agree). |
| Secondary | Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period | Baseline to 10 weeks | The Parkinson's Disease Questionnaire (PDQ-8) is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease. Each single item of the 8-item questionnaire ranges from 0 (never) to 4 (always). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Rotigotine Versus Placebo in the Absolute Time Spent Off From Baseline to the End of the 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. | ||
| SECONDARY | Change in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) Part III (Motor Examination) in the on State From Baseline to the End of the 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. | ||
| SECONDARY | Change in Predictability of Off Time (Using MDS UPDRS Part IV Item 4.5) From Baseline to End of the 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. | ||
| SECONDARY | Change in Score on Gastrointestinal Neurodegenerative Scale (GIND) From Baseline to the End of the of the 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. | ||
| SECONDARY | Change in Score on Fatigue Severity Scale (FSS) From Baseline to the End of 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. | ||
| SECONDARY | Change in Score on Parkinson's Disease Questionnaire (PDQ8) From Baseline to the End of 7-week Maintenance Period | Baseline to 10 weeks | This study was terminated early because of low enrollment. Due to the early termination no analysis tables of efficacy data were done and no descriptive summaries of efficacy data were produced. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | Rotigotine | 13 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | COMPLETED | Rotigotine | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 8 | |
| Overall Study | NOT COMPLETED | Rotigotine | 10 |
Source ClinicalTrials.gov
Adverse events38
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 |
|---|---|---|---|---|---|---|
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 0 | 12 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Rotigotine | 1 | 13 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Rotigotine | 0 | 13 | 0 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 1 | 12 | 1 |
| other | Vomiting | Gastrointestinal disorders | Rotigotine | 0 | 13 | 0 |
| other | Wound infection staphylococcal | Infections and infestations | Placebo | 0 | 12 | 0 |
| other | Wound infection staphylococcal | Infections and infestations | Rotigotine | 1 | 13 | 1 |
| other | Brain contusion | Injury, poisoning and procedural complications | Placebo | 0 | 12 | 0 |
| other | Brain contusion | Injury, poisoning and procedural complications | Rotigotine | 1 | 13 | 1 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Rotigotine | ||
| Total, other adverse events | Placebo | 4 | 12 |
| Total, other adverse events | Rotigotine | 5 | 13 |
| Total, serious adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Rotigotine | 1 | 13 |
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 |
|---|
| Rotigotine vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT01536015
GET https://conductscience.org/api/trials/v1/NCT01536015/events?page=2