Trial · NCT01723904
A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
NCT01723904, Phase 3, Completed, UCB BIOSCIENCES GmbH; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease. Trials, record NCT01723904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01723904
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease
- NCT number
- NCT01723904
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 90 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Advanced Parkinson's Disease
- Interventions
- Rotigotine
- First posted
- 2012-11-08
- Last updated
- 2014-06-03
- Results first posted
- 2014-06-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | The CGI Item 4 was used to assess side effects. It ranges from 0 to 4 as follows: 0 = Side effects not assessable 1. = No side effects 2. = Side effects do not significantly interfere with subject's functioning 3. = Side effects significantly interfere with the subject's functioning 4. = Side effects outweigh therapeutic efficacy. |
| Primary | Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III ("on" State) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | The Unified Parkinson´s Disease Rating Scale Part III is an accepted and validated scale for the assessment of motor function in Parkinson´s disease. Each of the 27 sub-items in the UPDRS III is measured on a scale of 0 to 4, where 0 is normal and 4 represents severe abnormalities. The total scores therefore ranges from 0 to 108. A negative value in Change from Baseline to Week 8 indicates an improvement in motor functions from Baseline. |
| Primary | Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of "on" and "Off" State) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | UPDRS Part II measures 'Activities in Daily Living'. The total score ranges from 0 (Best score possible) to 52 (Worst score possible). UPDRS Part II total score (average of "on" and "off" state) is the average of UPDRS Part II total score ("on" state) and Part II total score ("off" state). A negative value in Change from Baseline to Week 8 indicates an improvement in activities in daily living from Baseline. |
| Primary | Change From Baseline to the End of the Treatment Period in Absolute Time Spent "Off" | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Absolute time spent "off" is measured in hours per day. A negative value in Change from Baseline to Week 8 indicates that the time spent "off" decreased from Baseline and therefore indicates an improvement from Baseline. Only subjects with time spent "off" at Baseline (subset of the Full Analysis Set (FAS)) are included in the analysis of this outcome measure. |
| Secondary | Change From Baseline to the End of the Treatment Period in Time Spent "on" Without Troublesome Dyskinesia | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Absolute time spent "on" without troublesome dyskinesia is measured in hours per day. A positive value in Change from Baseline to Week 8 indicates that the time spent "on" without troublesome dyskinesia increased from Baseline and therefore indicates an improvement from Baseline. |
| Secondary | Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | The Parkinson´s Disease Sleep Scale (PDSS) is a questionnaire with 15 questions to assess sleep disturbance and nocturnal disability in Parkinson´s disease. The item- scores can range between 0= never and 4= very often. The PDSS score is a sum score of all 15 questions. A negative value in Change from Baseline to Week 8 indicates an improvement from Baseline. |
| Secondary | Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire with 18 questions to assess sleep quality. The 18 questions are distributed to 7 elements with each element ranging from 0-3. The global score is the sum score of all 7 elements and ranges from 0-21 with higher values indicating worse sleep quality. A negative value in Change from Baseline to Week 8 indicates an improvement in sleep quality from Baseline. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | From the 90 subjects in the Safatey Set, 89 are included in the analysis of this outcome measure. Last Observation Carried Forward (LOCF) was used as a method of imputation for missing observations. | participants | NUMBER |
| PRIMARY | Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (on State) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | units on a scale | MEAN |
| PRIMARY | Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of on and Off State) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | units on a scale | MEAN |
| PRIMARY | Change From Baseline to the End of the Treatment Period in Absolute Time Spent Off | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Subjects with time spent off at Baseline in the FAS with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | hours/day | MEAN |
| SECONDARY | Change From Baseline to the End of the Treatment Period in Time Spent on Without Troublesome Dyskinesia | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | hours/day | MEAN |
| SECONDARY | Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | units on a scale | MEAN |
| SECONDARY | Change From Baseline to the End of Treatment Period in the Pittsburgh Sleep Quality Index (PSQI) Global Score | From Baseline (Week 0) to Week 8 (Visit 8) of the 8 weeks Treatment Period (Titration and Maintenance Period) | Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF) as a method of imputation for missing observations. FAS includes all subjects with at least 1 patch application during Treatment Period, and with an evaluable UPDRS Part III total score at Baseline and at least 1 valid value after Baseline to Day 64. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Rotigotine | CGI Item 4 score of 1 | 61 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Rotigotine | CGI Item 4 score of 2 | 22 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Rotigotine | CGI Item 4 score of 3 | 3 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Rotigotine | CGI Item 4 score of 4 | 3 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period | Rotigotine | CGI Item 4 score of 3 or 4 | 6 | participants | |
| Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (on State) Total Score | Rotigotine | -5.3 | Standard Deviation 8.3 | units on a scale | |
| Change From Baseline to the End of the Treatment Period in the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Average of on and Off State) Total Score | Rotigotine | -1.5 | Standard Deviation 3.8 | units on a scale | |
| Change From Baseline to the End of the Treatment Period in Absolute Time Spent Off | Rotigotine | -2.1 | Standard Deviation 2.9 | hours/day | |
| Change From Baseline to the End of the Treatment Period in Time Spent on Without Troublesome Dyskinesia | Rotigotine | 1.9 | Standard Deviation 3.1 | hours/day | |
| Change From Baseline to the End of Treatment Period in Parkinson's Disease Sleep Scale 2 (PDSS-2) Total Score | Rotigotine | -3.2 | Standard Deviation 7.5 | units on a scale |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rotigotine | 90 | |
| Overall Study | COMPLETED | Rotigotine | 79 | |
| Overall Study | NOT COMPLETED | Rotigotine | 11 |
Source ClinicalTrials.gov
Adverse events12
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 | Nausea | Gastrointestinal disorders | Rotigotine | 7 | 90 | 9 |
| other | Application site pruritus | General disorders | Rotigotine | 12 | 90 | 12 |
| other | Nasopharyngitis | Infections and infestations | Rotigotine | 5 | 90 | 5 |
| other | Dizziness | Nervous system disorders | Rotigotine | 9 | 90 | 11 |
| other | Dyskinesia | Nervous system disorders | Rotigotine | 7 | 90 | 7 |
| other | Orthostatic hypotension | Vascular disorders | Rotigotine | 9 | 90 | 11 |
| serious | Subdural haemorrhage | Injury, poisoning and procedural complications | Rotigotine | 1 | 90 | 1 |
| serious | Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Rotigotine | 1 | 90 | 1 |
| serious | Confusional state | Psychiatric disorders | Rotigotine | 1 | 90 | 1 |
| serious | Delirium | Psychiatric disorders | Rotigotine | 1 | 90 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rotigotine | ||
| Total, other adverse events | Rotigotine | 35 | 90 |
| Total, serious adverse events | Rotigotine | 5 | 90 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25879416 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01723904
GET https://conductscience.org/api/trials/v1/NCT01723904/registered