Trial · NCT01485172
A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
NCT01485172, Phase 4, Completed, GlaxoSmithKline; results first posted 2015-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease. Trials, record NCT01485172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01485172
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's Disease
- NCT number
- NCT01485172
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 186 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- ropinirole monotherapy, placebo monotherapy
- First posted
- 2011-12-05
- Last updated
- 2018-06-20
- Results first posted
- 2015-02-02
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. One of the six features include the Part III - Motor Examination where scores can range 0-108 where the maximum score indicates the worse condition. 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 individual post-randomization values. The least squares(LS) means were estimated using the mixed model repeated measures(MMRM) adjusting for BL UPDRS motor score and race(white versus other) or by using the non-parametric rank analysis of covariance(ANCOVA). |
| Secondary | Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS motor scores can range from 0-108 where the maximum score indicates the worse condition. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. |
| Secondary | Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The responder rate is defined as the percentage of participants with a greater than or equal to (\>=)30% reduction in their individual Baseline UPDRS motor score at Week 4 of the Maintenance Period (Study Week 17). Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Change From Baseline in UPDRS Parts II and III Combined | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts II and III can range from 0-160 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Change From Baseline in UPDRS Activities of Daily Living | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The higher score indicates the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Change From Baseline in the Total UPDRS Score (Parts I-III) | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The total UPDRS score was calculated by the sum of the values for each component (Part I + Part II + Part III) as determined by the physician. The UPDRS Part I scores mentation, behavior and mood and scores can range from 0-16. The UPDRS Part II is the Activities of Daily Living (ADL) score and can range from 0-52. The UPDRS Part III is the Motor Examination (Total Motor Score \[TMS\]) and scores range from 0-108. The total UPDRS (Part I + II + III) scores can range from 0-176 with the higher score indicating the worse condition. Tests were performed when the participant is in the "on" state of Parkinson's. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Change From Baseline in the UPDRS Part I (Mentation) | Baseline and Week 4 of the Maintenance Period (Study Week 17) | The UPDRS Part I scores mentation, behavior and mood as determined by a physician and participants were tested during the "on" phase of Parkinson's. This component of the UPDRS is the total score for 4 items (the items 1- 4 include intellectual impairment, thought disorder, motivation/initiative, and depression) and may have a value ranging from 0 to 16 as determined by a physician where 16 indicates the maximum score and the worse condition. All 4 items have to be present for a total score to be calculated. If one or more items are missing, the total score for the component will also be missing. Baseline is defined as the last non-missing assessment measured on or before the first dose date. The change from Baseline will be calculated by subtracting the Baseline values from the individual post-randomization values. |
| Secondary | Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | Intent to Treat (ITT) Population: all randomized subjects who received at least one dose of study medication, had a Baseline efficacy assessment for the specific outcome, and had at least one respective efficacy outcome assessment collected after randomization (Baseline) visit, i.e. had at least one respective Post-Baseline efficacy assessment. | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Participants | NUMBER |
| SECONDARY | Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Participants | NUMBER |
| SECONDARY | Number of Participants With a >=10 Points Reduction From Baseline in UPDRS Parts II and III Combined | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Participants | NUMBER |
| SECONDARY | Responder Rate Defined as Participants With a >=30% Reduction in Baseline UPDRS Motor Score | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All 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 UPDRS Parts II and III Combined | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in UPDRS Activities of Daily Living | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total UPDRS Score (Parts I-III) | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the UPDRS Part I (Mentation) | Baseline and Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Responder Rate According to the Clinical Global Impression - Global Improvement (CGI-I) Scale | Week 4 of the Maintenance Period (Study Week 17) | ITT Population. All participants with a non-missing efficacy observation at Baseline and during the maintenance period were analyzed | Percentage of participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group66
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 Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group A: Placebo | -1.91 | 95% Confidence Interval -4.15 to 0.34 | Score on a scale | |
| Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group B: 2 mg/Day | -1.58 | 95% Confidence Interval -5.02 to 1.86 | Score on a scale | |
| Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group C: 4 mg/Day | -2.76 | 95% Confidence Interval -5.04 to -0.49 | Score on a scale | |
| Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group D: 8 mg/Day | -4.31 | 95% Confidence Interval -6.48 to -2.15 | Score on a scale | |
| Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group E: 12 mg/Day | -4.07 | 95% Confidence Interval -6.32 to -1.82 | Score on a scale | |
| Change From Baseline (BL) in Unified Parkinson Disease (PD) Rating Scale (UPDRS) Motor Score | Treatment Group F: 24 mg/Day | -2.83 | 95% Confidence Interval -6.61 to 0.95 | Score on a scale | |
| Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Treatment Group A: Placebo | 9 | Participants | ||
| Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Treatment Group B: 2 mg/Day | 6 | Participants | ||
| Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Treatment Group C: 4 mg/Day | 14 | Participants | ||
| Number of Participants With a >=5 Points Reduction From Baseline in UPDRS Motor Score | Treatment Group D: 8 mg/Day | 16 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 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 | 40 | |
| Overall Study | STARTED | Treatment Group B: 2 mg/Day | 13 | |
| Overall Study | STARTED | Treatment Group C: 4 mg/Day | 41 | |
| Overall Study | STARTED | Treatment Group D: 8 mg/Day | 40 | |
| Overall Study | STARTED | Treatment Group E: 12 mg/Day | 39 | |
| Overall Study | STARTED | Treatment Group F: 24 mg/Day | 13 | |
| Overall Study | COMPLETED | Treatment Group A: Placebo | 33 | |
| Overall Study | COMPLETED | Treatment Group B: 2 mg/Day | 12 | |
| Overall Study | COMPLETED | Treatment Group C: 4 mg/Day | 34 | |
| Overall Study | COMPLETED | Treatment Group D: 8 mg/Day | 32 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events210
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 | Somnolence | Nervous system disorders | Treatment Group A: Placebo | 2 | 40 | |
| other | Somnolence | Nervous system disorders | Treatment Group B: 2 mg/Day | 2 | 13 | |
| other | Somnolence | Nervous system disorders | Treatment Group C: 4 mg/Day | 5 | 41 | |
| other | Somnolence | Nervous system disorders | Treatment Group D: 8 mg/Day | 4 | 40 | |
| other | Somnolence | Nervous system disorders | Treatment Group E: 12 mg/Day | 3 | 39 | |
| other | Somnolence | Nervous system disorders | Treatment Group F: 24 mg/Day | 1 | 13 | |
| other | Headache | Nervous system disorders | Treatment Group A: Placebo | 1 | 40 | |
| other | Headache | Nervous system disorders | Treatment Group B: 2 mg/Day | 1 | 13 | |
| other | Headache | Nervous system disorders | Treatment Group C: 4 mg/Day | 4 | 41 | |
| other | Headache | Nervous system disorders | Treatment Group D: 8 mg/Day | 3 | 40 |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 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: 2 mg/Day | ||
| Total, all-cause mortality | Treatment Group C: 4 mg/Day | ||
| Total, all-cause mortality | Treatment Group D: 8 mg/Day | ||
| Total, all-cause mortality | Treatment Group E: 12 mg/Day | ||
| Total, all-cause mortality | Treatment Group F: 24 mg/Day | ||
| Total, other adverse events | Treatment Group A: Placebo | 17 | 40 |
| Total, other adverse events | Treatment Group B: 2 mg/Day | 5 | 13 |
| Total, other adverse events | Treatment Group C: 4 mg/Day | 18 | 41 |
| Total, other adverse events | Treatment Group D: 8 mg/Day | 24 | 40 |
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/NCT01485172
GET https://conductscience.org/api/trials/v1/NCT01485172/results?page=2