Trial · NCT01929317

A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.

NCT01929317, Phase 3, Terminated, GlaxoSmithKline; results first posted 2015-05-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients. Trials, record NCT01929317. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01929317

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.
NCT number: NCT01929317
Status: Terminated
Phases: Phase 3
Enrollment: 81 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Parkinson Disease
Interventions: Ropinirole CR 2mg tablet, Ropinirole CR 8mg tablet, Ropinirole CR matching Placebo tablet
First posted: 2013-08-27
Last updated: 2018-06-20
Results first posted: 2015-05-21

Source ClinicalTrials.gov

Registered outcomes31

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	Baseline and Week 12	The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Secondary	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese Unified Parkinson's Disease Rating Scale (UPDRS) assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Baseline is defined as the value evaluated at Week 0. Mean change from Baseline was calculated as the total score at Week 12 minus the total score at Baseline. The analyses for the Dose Increase Effect Verification Phase was performed using the last observation carried forward (LOCF) data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Secondary	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of Parkinson's Disease (PD) participants objectively. Part III assessed motor examination on 27 items. Participants received a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Number of participants achieving a 30% or greater and 20% or greater reduction from Baseline in UPDRS total part III score at Weeks 2, 4, 6, 8, and 12 are presented using LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. The imputation was conducted using the data within only the Dose Increase Effect Verification Phase; therefore, the value observed in the Dose Increase Effect Verification Phase was not used to impute a missing data in the Long-term Phase.
Secondary	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at the planned visit.
Secondary	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluated activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Secondary	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline value. Baseline is defined as the value evaluated at Week 0. The analyses for the Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Secondary	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part I evaluated mentation, behavior, and mood on 4 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 16. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Secondary	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assesses the status of PD participants objectively. Part 2 evaluates activities of daily living on 13 items, response for each item were scored numerically from 0-4. The total score for the 4 items ranged from 0 to 52. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "On" state is defined as the state at which PD symptoms are well controlled by the drug. The score of UPDRS part 2 in off status is rated as '0' (Normal/None), if L-dopa adjunct participants do not have diurnal fluctuations.
Secondary	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 3 evaluated motor examination on 27 items, response for each items were scored numerically from 0-4. The total score for the 27 items ranged from 0 to 108. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.
Secondary	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	The Japanese UPDRS assessed the status of PD participants objectively. Part 4 evaluated complications on 11 items, response for 4 items were scored numerically from 0-4 and response for other 7 items were Yes/No questions and responses are numerically scored as 0 for "No" and 1 for "Yes". The total score for the 11 items ranged from 0 to 23. A higher score indicates more severe PD symptoms. Percent change from Baseline was calculated as Post baseline value minus Baseline value, divided by Baseline value and multiplied by 100. Baseline is defined as the value evaluated at Week 0. The analyses for Dose Increase Effect Verification Phase was performed using the LOCF data. In the LOCF data, the last available data was used for the imputation for missing data at a planned visit.

1 to 10 of 31Source ClinicalTrials.gov

See all 31 registered outcomes

Outcomes31

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 (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	Baseline and Week 12	Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.	Scores on a scale	MEAN
SECONDARY	Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Baseline, Weeks, 2, 4, 6, 8 and 12	Full Analysis Set 1 (FAS1) Population: all participants excluding those participants who received no dose of study medication and participants without UPDRS part III total score data after supply of the investigational product.	Scores on a scale	MEAN
SECONDARY	Number of Participants Achieving a 30% and 20% Reduction From Baseline in the UPDRS Total Part 3 Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population	Participants	NUMBER
SECONDARY	Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population	Scores on a scale	MEAN
SECONDARY	Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.	Scores on a scale	MEAN
SECONDARY	Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population	Scores on a scale	MEAN
SECONDARY	Percent Change From Baseline in the Japanese UPDRS Part 1 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population. Only those participants available at the specified time points were analyzed.	Percent change	MEAN
SECONDARY	Percent Change From Baseline in the Japanese UPDRS Part 2 Total Score at the Indicated Visits by the on/Off Status in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population. Only those participants available at the specified time points were analyzed (represented by n=X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the FAS1 population.	Percent change	MEAN
SECONDARY	Percent Change From Baseline in the Japanese UPDRS Part 3 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population	Percent change	MEAN
SECONDARY	Percent Change From Baseline in the Japanese UPDRS Part 4 Total Score at the Indicated Visits in the Dose Increase Effect Verification Phase	Baseline, Weeks, 2, 4, 6, 8 and 12	FAS1 Population. Only those participants available at the specified time points were analyzed.	Percent change	MEAN

1 to 10 of 31Source ClinicalTrials.gov

See all 31 outcomes

Results by group381

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 (Week 0) in UPDRS Part III Total Score at Week 12 in the CR High-dose Group	Ropinirole CR - High Dose Group		-4.8	Standard Deviation 5.95	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - High Dose Group	Week 2	-2.9	Standard Deviation 4.41	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - Maintenance Dose Group	Week 2	-2.7	Standard Deviation 4.27	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - High Dose Group	Week 4	-3.8	Standard Deviation 5.23	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - Maintenance Dose Group	Week 4	-4.4	Standard Deviation 3.50	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - High Dose Group	Week 6	-4.6	Standard Deviation 5.28	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - Maintenance Dose Group	Week 6	-5.0	Standard Deviation 5.09	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - High Dose Group	Week 8	-5.2	Standard Deviation 5.46	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - Maintenance Dose Group	Week 8	-4.5	Standard Deviation 4.94	Scores on a scale
Mean Change From Baseline (Week 0) in UPDRS Part III Total Score at the Indicated Visits	Ropinirole CR - High Dose Group	Week 12	-4.8	Standard Deviation 5.95	Scores on a scale

1 to 10 of 381Source ClinicalTrials.gov

See all 381 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Dose Increase Effect Verification Phase	STARTED	Ropinirole CR - High Dose Group	61
Dose Increase Effect Verification Phase	STARTED	Ropinirole CR - Maintenance Dose Group	20
Dose Increase Effect Verification Phase	COMPLETED	Ropinirole CR - High Dose Group	52
Dose Increase Effect Verification Phase	COMPLETED	Ropinirole CR - Maintenance Dose Group	19
Dose Increase Effect Verification Phase	NOT COMPLETED	Ropinirole CR - High Dose Group	9
Dose Increase Effect Verification Phase	NOT COMPLETED	Ropinirole CR - Maintenance Dose Group	1
Long-term Phase	STARTED	Ropinirole CR - High Dose Group	44
Long-term Phase	STARTED	Ropinirole CR - Maintenance Dose Group	18
Long-term Phase	COMPLETED	Ropinirole CR - High Dose Group	25
Long-term Phase	COMPLETED	Ropinirole CR - Maintenance Dose Group	14

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events196

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
other	Dyskinesia	Nervous system disorders	Ropinirole CR - High Dose Group	3	61
other	Dyskinesia	Nervous system disorders	Ropinirole CR - Maintenance Group	2	20
other	Dyskinesia	Nervous system disorders	Ropinirole CR - High Dose Group: Long Term Phase	2	44
other	Dyskinesia	Nervous system disorders	Ropinirole CR - Maintenance Group: Long Term Phase	1	18
other	Somnolence	Nervous system disorders	Ropinirole CR - High Dose Group	4	61
other	Somnolence	Nervous system disorders	Ropinirole CR - Maintenance Group	1	20
other	Somnolence	Nervous system disorders	Ropinirole CR - High Dose Group: Long Term Phase	0	44
other	Somnolence	Nervous system disorders	Ropinirole CR - Maintenance Group: Long Term Phase	0	18
other	Sudden onset of sleep	Nervous system disorders	Ropinirole CR - High Dose Group	2	61
other	Sudden onset of sleep	Nervous system disorders	Ropinirole CR - Maintenance Group	2	20

1 to 10 of 196Source ClinicalTrials.gov

See all 196 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ropinirole CR - High Dose Group
Total, all-cause mortality	Ropinirole CR - Maintenance Group
Total, all-cause mortality	Ropinirole CR - High Dose Group: Long Term Phase
Total, all-cause mortality	Ropinirole CR - Maintenance Group: Long Term Phase
Total, other adverse events	Ropinirole CR - High Dose Group	13	61
Total, other adverse events	Ropinirole CR - Maintenance Group	11	20
Total, other adverse events	Ropinirole CR - High Dose Group: Long Term Phase	14	44
Total, other adverse events	Ropinirole CR - Maintenance Group: Long Term Phase	13	18
Total, serious adverse events	Ropinirole CR - High Dose Group	2	61
Total, serious adverse events	Ropinirole CR - Maintenance Group	4	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28442303	DERIVED

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Ropinirole CR - High Dose Group vs Ropinirole CR - Maintenance Dose Group: Number of Participants Remaining in the Study	Trial comparisons
Ropinirole CR - High Dose Group vs Ropinirole CR - Maintenance Dose Group: Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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