Trial · NCT01154166
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
NCT01154166, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa. Trials, record NCT01154166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01154166
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa
- NCT number
- NCT01154166
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 347 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- ReQuip PR, Placebo
- First posted
- 2010-06-30
- Last updated
- 2018-08-06
- Results first posted
- 2012-08-07
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in Total Awake Time Spent "Off" at Week 24 Using Last Observation Carried Forward (LOCF) | Baseline and Week 24 (Visit 13) | The "off" state is defined as the state in which Parkinson's Disease (PD) symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off " periods in 24-hour diary cards prior to each visit on two days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
| Secondary | Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | Baseline and Week 24 (Visit 13) | The UPDRS, a clinician-based rating scale, assesses 6 features of PD impairment: (1) mentation, behavior, and mood; (2) activities of daily living; (3) motor examination; (4) complications of therapy; (5) modified Hoehn and Yahr stage; (6) Schwab and England activities of daily living scale. Assessments were conducted when participants had benefit in regard to mobility, tremor, and rigidity. The total motor score (sum of motor examination) ranges from 0 to 108: 0=normal/no symptoms; 108=worst possible case. Change from BL was calculated as the value at Week 24 minus the value at BL. |
| Secondary | Mean Change From Baseline in the Percentage of Awake Time Spent "Off" (ATSO) at Week 24 Using LOCF | Baseline and Week 24 | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Participants were asked to record the duration of their "off" periods in 24-hour diary cards prior to each visit on the same 2 days of each relevant week. The total number of awake hours spent "off" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. The percentage of ATSO=ATSO divided by (ATSO + awake time spent "on") \* 100. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. |
| Secondary | Mean Change From Baseline in Total Awake Time Spent "on" at Week 24 Using LOCF | Baseline and Week 24 | The "on" state is defined as the state in which the PD symptoms (lack of mobility, tremor, or rigidity) are adequately controlled by the drug. Participants were asked to record the duration of their "on" periods in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent "on" per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
| Secondary | Mean Change From Baseline in Total Awake Time "on" Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Baseline and Week 24 | 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. Participants were asked to record the number of awake hours spent "on" without TD in 24-hour diary cards prior to each visit on the same two days of each relevant week. The total number of awake hours spent"on"without TD per 24-hour period was the sum of the hours recorded on the two 24-hour diary cards. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
| Secondary | Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF | Baseline and Week 24 | The UPDRS assesses six features of PD impairment, including Activities of Daily Living (ADL). The total ADL score ranges from 0 to 52, where 0= normal/no symptoms and 52= worst possible case. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
| Secondary | Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | Week 24 | The CGI global improvement scale allows the investigator to rate the participant's total improvement since the beginning of treatment (Baseline). Scores on the scale range from 1 to 7 (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, and 7=very much worse). Participants with a CGI global improvement score of \<=2 (representing much improved or very much improved) were considered to be responders. |
| Secondary | Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | Week 24 | In the event of unacceptable side effects relative to Baseline (e.g., dyskinesias, dystonias \[neurological movement disorder\]) the dosage of L-dopa was reduced. If there was reduction in the side effects and there was loss of symptom control, the dose of study medication was again increased (reinstated) at subsequent visits. If symptoms could still not be controlled, then L-dopa was reinstated; however, the dose could not exceed the baseline dose. |
| Secondary | Number of Responders to Study Treatment Using LOCF | Baseline to Week 24 | The "off" state is defined as the state in which PD symptoms (lack of mobility, tremor, or rigidity) are not adequately controlled by the drug. Responders are defined as participants who had at least a 20% reduction from Baseline in awake time spent "off" and at least a 20% reduction from Baseline in the L-dopa dose. |
| Secondary | Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF | Baseline and Week 24 | The HAMD-17 is a 17-item scale that is completed by the investigator. Each item was evaluated and scored using either a 5-point scale (e.g., absent, mild, moderate, severe, very severe) or a 3-point scale (e.g., absent, mild, marked). The total HAMD-17 score (sum of the scores of all 17 items) may range from 0 (least severe) to 52 (most severe). Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
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 | Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF) | Baseline and Week 24 (Visit 13) | Intent-to-treat (ITT) Population: all randomized participants who received at least one dose of study medication and for whom at least one post-baseline efficacy assessment was available. In the LOCF dataset, the last available on-therapy observation for a participant is used to estimate missing data points. | hours | MEAN |
| SECONDARY | Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | Baseline and Week 24 (Visit 13) | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Percentage of Awake Time Spent Off (ATSO) at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | Percentage of time | MEAN |
| SECONDARY | Mean Change From Baseline in Total Awake Time Spent on at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | hours | MEAN |
| SECONDARY | Mean Change From Baseline in Total Awake Time on Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Data were collected using the LOCF method. | hours | MEAN |
| SECONDARY | Mean Change From Baseline in the UPDRS Activities of Daily Living (ADL) Score at Week 24 Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
| SECONDARY | Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | Week 24 | ITT Population. Only those participants who had their dose of L-dopa reduced were included in this analysis. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Number of Responders to Study Treatment Using LOCF | Baseline to Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in the Depression Scores on the Hamilton Depression Rating Scale (HAMD-17) Using LOCF | Baseline and Week 24 | ITT Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | scores on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF) | Placebo | -0.4 | Standard Deviation 2.47 | hours | |
| Mean Change From Baseline in Total Awake Time Spent Off at Week 24 Using Last Observation Carried Forward (LOCF) | Ropinirole PR | -2.1 | Standard Deviation 2.58 | hours | |
| Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | Placebo | -0.7 | Standard Deviation 9.03 | scores on a scale | |
| Mean Change From Baseline (BL) in the Unified Parkinson Disease Rating Scale (UPDRS) Total Motor Score at Week 24 Using LOCF | Ropinirole PR | -6.3 | Standard Deviation 10.08 | scores on a scale | |
| Mean Change From Baseline in the Percentage of Awake Time Spent Off (ATSO) at Week 24 Using LOCF | Placebo | -1.8 | Standard Deviation 15.88 | Percentage of time | |
| Mean Change From Baseline in the Percentage of Awake Time Spent Off (ATSO) at Week 24 Using LOCF | Ropinirole PR | -13.5 | Standard Deviation 15.62 | Percentage of time | |
| Mean Change From Baseline in Total Awake Time Spent on at Week 24 Using LOCF | Placebo | 0.1 | Standard Deviation 2.48 | hours | |
| Mean Change From Baseline in Total Awake Time Spent on at Week 24 Using LOCF | Ropinirole PR | 1.9 | Standard Deviation 2.44 | hours | |
| Mean Change From Baseline in Total Awake Time on Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Placebo | 0.3 | Standard Deviation 2.56 | hours | |
| Mean Change From Baseline in Total Awake Time on Without Troublesome Dyskinesias (TD) at Week 24 Using LOCF | Ropinirole PR | 1.7 | Standard Deviation 2.81 | hours |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 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 | 169 | |
| Overall Study | STARTED | Ropinirole PR | 175 | |
| Overall Study | COMPLETED | Placebo | 135 | |
| Overall Study | COMPLETED | Ropinirole PR | 163 | |
| Overall Study | NOT COMPLETED | Placebo | 34 | |
| Overall Study | NOT COMPLETED | Ropinirole PR | 12 |
Source ClinicalTrials.gov
Adverse events334
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 | Dyskinesia | Nervous system disorders | Placebo | 5 | 170 | |
| other | Dyskinesia | Nervous system disorders | Ropinirole PR | 31 | 175 | |
| other | Dizziness | Nervous system disorders | Placebo | 12 | 170 | |
| other | Dizziness | Nervous system disorders | Ropinirole PR | 16 | 175 | |
| other | Somnolence | Nervous system disorders | Placebo | 7 | 170 | |
| other | Somnolence | Nervous system disorders | Ropinirole PR | 10 | 175 | |
| other | Headache | Nervous system disorders | Placebo | 3 | 170 | |
| other | Headache | Nervous system disorders | Ropinirole PR | 3 | 175 | |
| other | Akinesia | Nervous system disorders | Placebo | 3 | 170 | |
| other | Akinesia | Nervous system disorders | Ropinirole PR | 2 | 175 |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 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 | Ropinirole PR | ||
| Total, other adverse events | Placebo | 105 | 170 |
| Total, other adverse events | Ropinirole PR | 129 | 175 |
| Total, serious adverse events | Placebo | 8 | 170 |
| Total, serious adverse events | Ropinirole PR | 9 | 175 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ropinirole PR vs Placebo: Number of Responders Based on the Clinical Global Impression (CGI) Global Improvement Scale Using LOCF | Trial comparisons |
| Ropinirole PR vs Placebo: Number of Responders to Study Treatment Using LOCF | Trial comparisons |
| Ropinirole PR vs Placebo: Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF | Trial comparisons |
| Ropinirole PR vs Placebo: serious adverse events | 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/NCT01154166
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