Trial · NCT01646255
Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients
NCT01646255, Phase 3, Completed, UCB Pharma; results first posted 2016-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients. Trials, record NCT01646255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients
- NCT number
- NCT01646255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 346 participants, actual
- Lead sponsor
- UCB Pharma
- Conditions
- Idiopathic Parkinson's Disease
- Interventions
- Rotigotine, Placebo Patch, L-dopa
- First posted
- 2012-07-20
- Last updated
- 2018-04-04
- Results first posted
- 2016-01-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. A negative mean indicates a reduction of the time off during the conduct of the study |
| Secondary | Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A Responder is defined as a subject with an ≥ 30 % decrease in absolute time spent 'off' |
| Secondary | Percent Change in Absolute Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Absolute time "off" is defined as the mean number of hours marked "off" during a 24-hour period from all valid daily diary cards. |
| Secondary | Percent Change in Relative Time Spent "Off" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. Relative time spent "off" will be calculated in two stages. Each valid daily diary will have an associated relative time "off" calculated as relative time "off" for day = 100\*\[total absolute time "off" for day/ absolute time awake for day\]. Relative time spent "off" is then calculated by averaging the daily relative time "off" for the valid days of that visit. |
| Secondary | Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Absolute time "on" is defined as the mean number of hours marked "on" during a 24-hour period from all valid daily diary cards. |
| Secondary | Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit. |
| Secondary | Percent Change in Absolute Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. Note for percent change calculations: when absolute time at Baseline was 0 hours, the absolute Baseline value was assumed to be 1 minute for calculation purposes. |
| Secondary | Percent Change in Relative Time Spent "on" From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was "off" when taking his/her L-dopa, he/she recorded the exact time their status changed to "on". Note for percent change calculations: when relative time at Baseline was 0%, the relative Baseline value was assumed to be 0.1 for calculation purposes. Relative time spent "on" will be calculated in two stages. Each valid daily diary will have an associated relative time "on" calculated as relative time "on" for day = 100\*\[total absolute time "on" for day/ absolute time awake for day\]. Relative time spent "on" is then calculated by averaging the daily relative time "on" for the valid days of that visit. |
| Secondary | Change in the Number of "Off" Periods From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "off" when he/she began to lose the optimum effects of anti-Parkinson's medication. |
| Secondary | Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | A subject has been considered "on" when he/she felt the effects of L-dopa. The subject recorded the exact time of L-dopa intake and his/her status at the time of the L-dopa dose. In instances when the subject was 'off' when taking his/her L-dopa, he/she recorded the exact time their status changed to 'on'. The percentage of days from Baseline to the end of the double-blind Maintenance Period in which the subject woke in the "on with troublesome dyskinesia" state is presented below. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | hours | MEAN |
| SECONDARY | Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percentage of participants | NUMBER |
| SECONDARY | Percent Change in Absolute Time Spent Off From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percent change | MEAN |
| SECONDARY | Percent Change in Relative Time Spent Off From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percent change | MEAN |
| SECONDARY | Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | hours | MEAN |
| SECONDARY | Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | hours | MEAN |
| SECONDARY | Percent Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percent change | MEAN |
| SECONDARY | Percent Change in Relative Time Spent on From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percent change | MEAN |
| SECONDARY | Change in the Number of Off Periods From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | Number of 'off' Periods | MEAN |
| SECONDARY | Change in Status of the Subject (on) After Wake-up With Troublesome Dyskinesia From Baseline to the End of Double-blind Maintenance Period | From Baseline (Week 0) to end of Maintenance Period (up to Week 12) | The Full Analysis Set (FAS) consisted of all subjects who have been randomized, received at least 1 dose of study medication, had a valid Baseline primary efficacy measurement, and had at least 1 valid post-Baseline primary efficacy measurement. | percentage of days | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Placebo Treated Subjects) | -1.13 | Standard Deviation 3.20 | hours | |
| Absolute Change in Absolute Time Spent 'Off' From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Rotigotine Treated Subjects) | -2.36 | Standard Deviation 2.83 | hours | |
| Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period | Full Analysis Set (Placebo Treated Subjects) | 36.9 | percentage of participants | ||
| Percentage of Responders From Baseline to the End of the Doubleblind Maintenance Period | Full Analysis Set (Rotigotine Treated Subjects) | 48.8 | percentage of participants | ||
| Percent Change in Absolute Time Spent Off From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Placebo Treated Subjects) | -15.0 | Standard Deviation 56.56 | percent change | |
| Percent Change in Absolute Time Spent Off From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Rotigotine Treated Subjects) | -36.03 | Standard Deviation 43.03 | percent change | |
| Percent Change in Relative Time Spent Off From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Placebo Treated Subjects) | -14.86 | Standard Deviation 53.26 | percent change | |
| Percent Change in Relative Time Spent Off From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Rotigotine Treated Subjects) | -34.97 | Standard Deviation 43.87 | percent change | |
| Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Placebo Treated Subjects) | 0.94 | Standard Deviation 3.08 | hours | |
| Change in Absolute Time Spent on From Baseline to the End of Double-blind Maintenance Period | Full Analysis Set (Rotigotine Treated Subjects) | 2.05 | Standard Deviation 2.98 | hours |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 172 | |
| Overall Study | STARTED | Rotigotine | 174 | |
| Overall Study | COMPLETED | Placebo | 151 | |
| Overall Study | COMPLETED | Rotigotine | 160 | |
| Overall Study | NOT COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Rotigotine | 14 |
Source ClinicalTrials.gov
Adverse events30
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 | Placebo | 2 | 172 | 2 |
| other | Nausea | Gastrointestinal disorders | Rotigotine | 16 | 174 | 23 |
| other | Dyskinesia | Nervous system disorders | Placebo | 7 | 172 | 7 |
| other | Dyskinesia | Nervous system disorders | Rotigotine | 11 | 174 | 13 |
| other | Dizziness | Nervous system disorders | Placebo | 7 | 172 | 8 |
| other | Dizziness | Nervous system disorders | Rotigotine | 19 | 174 | 21 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Placebo | 10 | 172 | 11 |
| other | Pruritus | Skin and subcutaneous tissue disorders | Rotigotine | 14 | 174 | 15 |
| serious | Mitral valve prolapse | Cardiac disorders | Placebo | 1 | 172 | 1 |
| serious | Mitral valve prolapse | Cardiac disorders | Rotigotine | 0 | 174 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 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 | 24 | 172 |
| Total, other adverse events | Rotigotine | 54 | 174 |
| Total, serious adverse events | Placebo | 6 | 172 |
| Total, serious adverse events | Rotigotine | 6 | 174 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28827011 | 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 |
|---|
| 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/NCT01646255
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