Trial · NCT01711866
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
NCT01711866, Phase 4, Completed, UCB BIOSCIENCES GmbH; results first posted 2014-04-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease. Trials, record NCT01711866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01711866
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
- NCT number
- NCT01711866
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 87 participants, actual
- Lead sponsor
- UCB BIOSCIENCES GmbH
- Conditions
- Advanced Idiopathic Parkinson's Disease
- Interventions
- Rotigotine
- First posted
- 2012-10-22
- Last updated
- 2014-04-07
- Results first posted
- 2014-04-07
Source ClinicalTrials.gov
Registered outcomes2
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 or Early Withdrawal Visit | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit | 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. |
| Secondary | Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit | The PGIC is a 7-point categorical rating scale in which the subject rates the changes in functioning over time as follows: * 1 = Very much improved * 2 = Much improved * 3 = Minimally improved * 4 = No change * 5 = Minimally worse * 6 = Much worse * 7 = Very much worse. |
Source ClinicalTrials.gov
Outcomes2
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 or Early Withdrawal Visit | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit | All 87 subjects of the Safety Set 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 |
| SECONDARY | Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Day 28 (Visit 5) of the 28 days Treatment Period or Early Withdrawal Visit | 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 35. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
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 or Early Withdrawal Visit | Rotigotine | CGI Item 4 score of 1 | 58 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | CGI Item 4 score of 2 | 26 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | CGI Item 4 score of 3 | 3 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | CGI Item 4 score of 4 | 0 | participants | |
| Clinical Global Impression (CGI) Item 4 (Side Effects) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | CGI Item 4 score of 3 or 4 | 3 | participants | |
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | PGIC category 1 | 5 | participants | |
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | PGIC category 2 | 17 | participants | |
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | PGIC category 3 | 30 | participants | |
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | PGIC category 4 | 18 | participants | |
| Patients Global Impressions of Change (PGIC) at the End of the Treatment Period or Early Withdrawal Visit | Rotigotine | PGIC category 5 | 10 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 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 | 87 | |
| Overall Study | COMPLETED | Rotigotine | 79 | |
| Overall Study | NOT COMPLETED | Rotigotine | 8 |
Source ClinicalTrials.gov
Adverse events7
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 | Application site pruritus | General disorders | Rotigotine | 9 | 87 | 9 |
| other | Application site erythema | General disorders | Rotigotine | 6 | 87 | 6 |
| other | Dizziness | Nervous system disorders | Rotigotine | 6 | 87 | 6 |
| other | Dyskinesia | Nervous system disorders | Rotigotine | 6 | 87 | 6 |
| other | Erythema | Skin and subcutaneous tissue disorders | Rotigotine | 5 | 87 | 5 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Rotigotine | 5 | 87 | 5 |
| serious | Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Rotigotine | 1 | 87 | 1 |
Source ClinicalTrials.gov
Adverse 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 | 30 | 87 |
| Total, serious adverse events | Rotigotine | 1 | 87 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25846031 | 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/NCT01711866
GET https://conductscience.org/api/trials/v1/NCT01711866/registered