Trial · NCT00599339
Transdermal Rotigotine User Surveillance Study
NCT00599339, Completed, UCB Pharma; results first posted 2015-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Transdermal Rotigotine User Surveillance Study. Trials, record NCT00599339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00599339
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Transdermal Rotigotine User Surveillance Study
- NCT number
- NCT00599339
- Status
- Completed
- Enrollment
- 2,195 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Idiopathic Parkinson Disease
- First posted
- 2008-01-23
- Last updated
- 2018-08-09
- Results first posted
- 2015-04-29
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome). |
| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day). |
| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling). |
| Secondary | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 33 months | The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day). |
| Secondary | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 33 months | The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale. The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7. |
| Secondary | Hoehn & Yahr Stage at Visit 7 (Month 33) | 33 months | The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician. Possible staging: * 0 No signs of disease * 1 Unilateral disease * 2 Bilateral disease without impairment of balance * 3 Mild to moderate bilateral disease, some postural instability, physically dependent * 4 Severe disability, still able to walk or stand unassisted * 5 Wheelchair bound or bedridden unless aided |
| Secondary | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | 33 months | The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine. |
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 | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) | From Baseline to Visit 7 (Month 33) | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) | 33 months | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) | 33 months | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | units on a scale | MEAN |
| SECONDARY | Hoehn & Yahr Stage at Visit 7 (Month 33) | 33 months | All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).~Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. | participants | NUMBER |
| SECONDARY | Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) | 33 months | For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups. | Adverse Events | NUMBER |
Source ClinicalTrials.gov
Results by group198
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 Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Neupro Monotherapy (>= 3 Months) | -2.5 | Standard Deviation 14.7 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Neupro Monotherapy (< 3 Months) | -2.5 | Standard Deviation 10.3 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Other Dopamine Agonist (>= 3 Months) | -2.2 | Standard Deviation 11.1 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Other Dopamine Agonist (< 3 Months) | -5.6 | Standard Deviation 16.9 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | L-Dopa Monotherapy (>= 3 Months) | 0.2 | Standard Deviation 13.2 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | L-Dopa Monotherapy (< 3 Months) | 0.0 | Standard Deviation 12.2 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Multiple Dopamine Agonists (>= 3 Months) | -1.2 | Standard Deviation 13.8 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Multiple Dopamine Agonists (< 3 Months) | 3.5 | Standard Deviation 6.4 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Neupro + L-Dopa (>= 3 Months) | -1.2 | Standard Deviation 14.2 | units on a scale | |
| Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) | Neupro + L-Dopa (< 3 Months) | -1.5 | Standard Deviation 17.5 | units on a scale |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Overall | 2,195 | |
| Overall Study | Safety Set | Overall | 2,179 | |
| Overall Study | COMPLETED | Overall | 1,531 | |
| Overall Study | NOT COMPLETED | Overall | 664 |
Source ClinicalTrials.gov
Adverse events810
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 | Associated With Rotigotine | 105 | 1,390 | 120 |
| other | Nausea | Gastrointestinal disorders | Not Associated With Rotigotine | 85 | 1,328 | 101 |
| other | Fatigue | General disorders | Associated With Rotigotine | 67 | 1,390 | 76 |
| other | Fatigue | General disorders | Not Associated With Rotigotine | 77 | 1,328 | 82 |
| other | Fall | Injury, poisoning and procedural complications | Associated With Rotigotine | 49 | 1,390 | 60 |
| other | Fall | Injury, poisoning and procedural complications | Not Associated With Rotigotine | 67 | 1,328 | 79 |
| other | Depression | Psychiatric disorders | Associated With Rotigotine | 54 | 1,390 | 55 |
| other | Depression | Psychiatric disorders | Not Associated With Rotigotine | 72 | 1,328 | 74 |
| serious | Anaemia | Blood and lymphatic system disorders | Associated With Rotigotine | 1 | 1,390 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Not Associated With Rotigotine | 3 | 1,328 | 3 |
1 to 10 of 810Source ClinicalTrials.gov
See all 810 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Associated With Rotigotine | ||
| Total, all-cause mortality | Not Associated With Rotigotine | ||
| Total, other adverse events | Associated With Rotigotine | 237 | 1,390 |
| Total, other adverse events | Not Associated With Rotigotine | 245 | 1,328 |
| Total, serious adverse events | Associated With Rotigotine | 261 | 1,390 |
| Total, serious adverse events | Not Associated With Rotigotine | 269 | 1,328 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29484495 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Associated With Rotigotine vs Not Associated With Rotigotine: 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.
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