Trial · NCT00823836
Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
NCT00823836, Phase 3, Completed, GlaxoSmithKline; results first posted 2011-10-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease. Trials, record NCT00823836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00823836
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
- NCT number
- NCT00823836
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 302 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- ropinirole PR/XR, ropinirole IR
- First posted
- 2009-01-16
- Last updated
- 2017-01-18
- Results first posted
- 2011-10-07
Source ClinicalTrials.gov
Registered outcomes62
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis. |
| Secondary | Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis. |
| Secondary | Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. |
| Secondary | Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0. |
| Secondary | Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at "Off") total score were not included in the analysis. |
| Secondary | Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. |
| Secondary | Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. |
| Secondary | Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug. |
| Secondary | Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. |
| Secondary | Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 registered outcomesOutcomes62
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2. | scores on a scale | MEAN |
| SECONDARY | Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | FAP (up to Week 24) | FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation. | percentage of participants | NUMBER |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part II (at Off) Total Score at Week 24 in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part II (at On) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part II (at Off) Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
| SECONDARY | Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase | Week 0 and FAP (up to Week 24) | FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP. | scores on a scale | MEAN |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 outcomesResults by group334
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole PR-Ropinirole PR | -10.8 | Standard Deviation 8.32 | scores on a scale | |
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole IR-Ropinirole PR | -11.0 | Standard Deviation 7.56 | scores on a scale | |
| Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole PR-Ropinirole PR | 30 percent responder | 66 | percentage of participants | |
| Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole IR-Ropinirole PR | 30 percent responder | 69 | percentage of participants | |
| Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole PR-Ropinirole PR | 20 percent responder | 81 | percentage of participants | |
| Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole IR-Ropinirole PR | 20 percent responder | 78 | percentage of participants | |
| Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole PR-Ropinirole PR | -0.2 | Standard Deviation 1.25 | scores on a scale | |
| Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole IR-Ropinirole PR | -0.3 | Standard Deviation 1.21 | scores on a scale | |
| Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole PR-Ropinirole PR | -2.6 | Standard Deviation 3.69 | scores on a scale | |
| Mean Change From Week 0 in the Japanese UPDRS Part II (at On) Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase | Ropinirole IR-Ropinirole PR | -2.9 | Standard Deviation 4.17 | scores on a scale |
1 to 10 of 334Source ClinicalTrials.gov
See all 334 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| NV and PR/XR Switching Phases | STARTED | Ropinirole PR-Ropinirole PR | 156 | |
| NV and PR/XR Switching Phases | STARTED | Ropinirole IR-Ropinirole PR | 146 | |
| NV and PR/XR Switching Phases | COMPLETED | Ropinirole PR-Ropinirole PR | 124 | |
| NV and PR/XR Switching Phases | COMPLETED | Ropinirole IR-Ropinirole PR | 117 | |
| NV and PR/XR Switching Phases | NOT COMPLETED | Ropinirole PR-Ropinirole PR | 32 | |
| NV and PR/XR Switching Phases | NOT COMPLETED | Ropinirole IR-Ropinirole PR | 29 | |
| Long-term Phase | STARTED | Ropinirole PR-Ropinirole PR | 73 | |
| Long-term Phase | STARTED | Ropinirole IR-Ropinirole PR | 84 | |
| Long-term Phase | COMPLETED | Ropinirole PR-Ropinirole PR | 68 | |
| Long-term Phase | COMPLETED | Ropinirole IR-Ropinirole PR | 79 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events104
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 | Ropinirole PR-Ropinirole PR | 18 | 156 | |
| other | Somnolence | Nervous system disorders | Ropinirole IR-Ropinirole PR | 17 | 146 | |
| other | Dyskinesia | Nervous system disorders | Ropinirole PR-Ropinirole PR | 9 | 156 | |
| other | Dyskinesia | Nervous system disorders | Ropinirole IR-Ropinirole PR | 17 | 146 | |
| other | Dizziness | Nervous system disorders | Ropinirole PR-Ropinirole PR | 3 | 156 | |
| other | Dizziness | Nervous system disorders | Ropinirole IR-Ropinirole PR | 12 | 146 | |
| other | Nausea | Gastrointestinal disorders | Ropinirole PR-Ropinirole PR | 20 | 156 | |
| other | Nausea | Gastrointestinal disorders | Ropinirole IR-Ropinirole PR | 17 | 146 | |
| other | Constipation | Gastrointestinal disorders | Ropinirole PR-Ropinirole PR | 14 | 156 | |
| other | Constipation | Gastrointestinal disorders | Ropinirole IR-Ropinirole PR | 11 | 146 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ropinirole PR-Ropinirole PR | ||
| Total, all-cause mortality | Ropinirole IR-Ropinirole PR | ||
| Total, other adverse events | Ropinirole PR-Ropinirole PR | 95 | 156 |
| Total, other adverse events | Ropinirole IR-Ropinirole PR | 98 | 146 |
| Total, serious adverse events | Ropinirole PR-Ropinirole PR | 16 | 156 |
| Total, serious adverse events | Ropinirole IR-Ropinirole PR | 16 | 146 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ropinirole PR-Ropinirole PR vs Ropinirole IR-Ropinirole PR: 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/NCT00823836
GET https://conductscience.org/api/trials/v1/NCT00823836/registered?page=2