Trial · NCT01494532
A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease
NCT01494532, Phase 4, Completed, GlaxoSmithKline; results first posted 2015-12-03
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease. Trials, record NCT01494532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01494532
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's Disease
- NCT number
- NCT01494532
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 352 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- ropinirole/L-dopa, placebo/L-dopa
- First posted
- 2011-12-19
- Last updated
- 2018-06-20
- Results first posted
- 2015-12-03
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Total Awake Time Spent "Off" at Week 4 of Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | "Off" time is defined as the state in which the participants(par) symptoms include lack of mobility(bradykinesia) with or without additional features such as tremor or rigidity. Par were asked to record awake time "off ", awake time "on", troublesome dyskinesias(TD) during awake time "on", or time asleep for 30 minute intervals in 24 hr diary cards for 2 days preceding visits. Total number of awake hrs spent "off" per 24-hr period was the average of the 2 diary cards of the sum of awake hours spent "off" in each 24-hr diary card. BL is the last non-missing assessment measured on or before the first dose, change from BL was calculated by subtracting the BL values from the MP Week 4 values. Mixed Model Repeated Measures (MMRM) model used BL total awake time 'Off', treatment, visit and treatment by visit |
| Secondary | Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) "Off" Time at Week-4 of Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | The responder rate was defined as the percentage of par with greater than or equal to (\>=) 20 percent (%) reduction in their individual BL "off" time at Week 4 of the Maintenance Period. The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. Responder Rate (Least Squares \[LS\] means on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline total awake time 'Off', treatment, visit and treatment\*visit are included in the model. |
| Secondary | Percentage of Participants With a >=1 Hour Reduction in Baseline "Off" Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment\*visit are included in the model. |
| Secondary | Percentage of Participants With a >=2 Hours Reduction in Baseline "Off" Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The "off" time is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia) with or without additional features such as tremor or rigidity. BL is defined as the last non-missing assessment measured on or before the first dose date. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. Percentage of participants meeting the criterion (LS mean on inverse linked scale), odds ratio with 95% CI and p-value comparing against placebo were estimated by Generalized Estimating Equations (GEE) model. Baseline 'off-time', treatment, visit and treatment\*visit are included in the model. |
| Secondary | Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | The CGI-I scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The scale is rated from 1-7 where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse, 6 = "much worse", and 7 = "very much worse". The responder rate is defined as the percentage of participants with a score of 1 or 2. The Generalized Estimating Equations (GEE) model was used to determine CGI responder rate with treatment, visit, and treatment by visit interaction included in the model. Only scheduled visits were included. |
| Secondary | Change From Baseline in Absolute Awake Time Spent "on" Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in Parkinson's Disease (PD). TD is defined as those movements that interfere with function and cause meaningful discomfort. Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit. The total number of awake hours spent "on" without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" without TD in each 24 hour diary card. The change from BL was calculated by subtracting the BL values from the MP Week 4 values. LS means, 95% CIs and P-values were estimated from Mixed Model Repeated Measures (MMRM). Par with a non-missing efficacy observation at BL and during the MP were analyzed. |
| Secondary | Change From Baseline in Absolute Awake Time Spent "on" at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | Par were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" per 24-hour period was the average across the 2 diary cards of the sum of the awake hours spent "on" in each 24 hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM. |
| Secondary | Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total sleep hours during the night time hours of sleep was the average across the 2 diary cards of the sum of time (hours) asleep during night time in each 24-hour diary card. BL is defined as the last non-missing assessment measured on or before the first dose date. The change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values. LS means, 95% CIs and P-values were estimated from MMRM. |
| Secondary | Percent Change From Baseline in Awake Time Spent "Off" at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The "off" state is defined as the state in which the participants' symptoms include lack of mobility (bradykinesia), with or without additional features such as tremor or rigidity. Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "off" per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "off" in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values multiplied (×) the results with 100. LS means, 95% CIs and P-values were estimated from MMRM. |
| Secondary | Percent Change From Baseline in Awake Time Spent "on" Without TD at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | Dyskinesias are involuntary twisting, turning movements caused by medication during "on" time in PD. TD is defined as those movements that interfere with function and cause meaningful discomfort. Par. were asked to record awake time "off", awake time "on", TD during awake time "on", or time asleep for all 30 minute time intervals in 24 hour diary cards for the 2 days preceding each visit of the study. The total number of awake hours spent "on" without TD per 24-hour period was the average across the 2 diary cards of the sum of awake hours spent "on" without TD in each 24-hour diary card. The percent change from BL was calculated by subtracting the BL values from the Maintenance Period Week 4 values divided by BL values × 100. LS means, 95% CIs and P-values were estimated from MMRM. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The Intent to Treat(ITT) Population included all randomized par who received at least one dose of study medication, had a BL efficacy assessment for the outcome, and at least one respective Post-BL efficacy assessment. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a >=1 Hour Reduction in Baseline Off Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With a >=2 Hours Reduction in Baseline Off Time at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | percentage of participants | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate According to the Clinical Global Impression-global Improvement (CGI-I) Scale at Week 4 of the Maintenance Period | Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Absolute Awake Time Spent on Without Troublesome Dyskinesia (TD) at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Absolute Awake Time Spent on at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline for Total Sleep Time During the Night Time Hours of Sleep at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Awake Time Spent Off at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of off time in hours | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Awake Time Spent on Without TD at Week 4 of the Maintenance Period | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. Participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed. | Percentage of on time in hours | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group A: Placebo | -1.91 | 95% Confidence Interval -2.46 to -1.35 | Hours | |
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group B: 4 mg/Day | -2.04 | 95% Confidence Interval -3.02 to -1.06 | Hours | |
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group C: 8 mg/Day | -2.92 | 95% Confidence Interval -3.50 to -2.34 | Hours | |
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group D: 12 mg/Day | -2.34 | 95% Confidence Interval -2.91 to -1.76 | Hours | |
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group E: 16 mg/Day | -2.80 | 95% Confidence Interval -3.36 to -2.24 | Hours | |
| Change From Baseline (BL) in Total Awake Time Spent Off at Week 4 of Maintenance Period | Treatment Group F: 24 mg/Day | -2.37 | 95% Confidence Interval -3.26 to -1.47 | Hours | |
| Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Treatment Group A: Placebo | 65.4 | 95% Confidence Interval 52.4 to 76.4 | percentage of participants | |
| Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Treatment Group B: 4 mg/Day | 68.0 | 95% Confidence Interval 46.6 to 83.8 | percentage of participants | |
| Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Treatment Group C: 8 mg/Day | 75.4 | 95% Confidence Interval 63.0 to 84.6 | percentage of participants | |
| Responder Rate Defined as the Percentage of Participants With a 20% Reduction in Baseline (BL) Off Time at Week-4 of Maintenance Period | Treatment Group D: 12 mg/Day | 64.3 | 95% Confidence Interval 50.8 to 75.8 | percentage of participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group A: Placebo | 75 | |
| Overall Study | STARTED | Treatment Group B: 4 mg/Day | 25 | |
| Overall Study | STARTED | Treatment Group C: 8 mg/Day | 76 | |
| Overall Study | STARTED | Treatment Group D: 12 mg/Day | 75 | |
| Overall Study | STARTED | Treatment Group E: 16 mg/Day | 76 | |
| Overall Study | STARTED | Treatment Group F: 24 mg/Day | 25 | |
| Overall Study | COMPLETED | Treatment Group A: Placebo | 65 | |
| Overall Study | COMPLETED | Treatment Group B: 4 mg/Day | 21 | |
| Overall Study | COMPLETED | Treatment Group C: 8 mg/Day | 59 | |
| Overall Study | COMPLETED | Treatment Group D: 12 mg/Day | 60 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events96
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 | Constipation | Gastrointestinal disorders | Treatment Group A: Placebo | 4 | 75 | |
| other | Constipation | Gastrointestinal disorders | Treatment Group B: 4 mg/Day | 0 | 25 | |
| other | Constipation | Gastrointestinal disorders | Treatment Group C: 8 mg/Day | 0 | 76 | |
| other | Constipation | Gastrointestinal disorders | Treatment Group D: 12 mg/Day | 0 | 75 | |
| other | Constipation | Gastrointestinal disorders | Treatment Group E: 16 mg/Day | 0 | 76 | |
| other | Constipation | Gastrointestinal disorders | Treatment Group F: 24 mg/Day | 0 | 25 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group A: Placebo | 8 | 75 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group B: 4 mg/Day | 1 | 25 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group C: 8 mg/Day | 5 | 76 | |
| other | Nausea | Gastrointestinal disorders | Treatment Group D: 12 mg/Day | 8 | 75 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group A: Placebo | ||
| Total, all-cause mortality | Treatment Group B: 4 mg/Day | ||
| Total, all-cause mortality | Treatment Group C: 8 mg/Day | ||
| Total, all-cause mortality | Treatment Group D: 12 mg/Day | ||
| Total, all-cause mortality | Treatment Group E: 16 mg/Day | ||
| Total, all-cause mortality | Treatment Group F: 24 mg/Day | ||
| Total, other adverse events | Treatment Group A: Placebo | 31 | 75 |
| Total, other adverse events | Treatment Group B: 4 mg/Day | 9 | 25 |
| Total, other adverse events | Treatment Group C: 8 mg/Day | 27 | 76 |
| Total, other adverse events | Treatment Group D: 12 mg/Day | 40 | 75 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 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/NCT01494532
GET https://conductscience.org/api/trials/v1/NCT01494532/registered?page=2