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Comparison · NCT01929317-9e9a77c8

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

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT01929317-9e9a77c8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01929317-9e9a77c8

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3650.2480.501wilson
Risk in group 20.3160.1540.54wilson
Risk difference, group 1 minus group 20.0496-0.2030.261newcombe hybrid score
Risk ratio, group 1 over group 21.160.5452.46log
Odds ratio, group 1 over group 21.250.4073.82log
Number needed to treat, for one more participant with the outcome on Ropinirole CR - High Dose Group than on Ropinirole CR - Maintenance Dose Group20.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Ropinirole CR - High Dose Group
Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
1952OG000
Group 2Ropinirole CR - Maintenance Dose Group
Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
619OG001

Outcome

Type
SECONDARY
Title
Number of Participants With an Improvement (Responder) in the Clinical Global Impression (CGI) Global Improvement Scale at Week 12
Description
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 moderate improvement (responder). The analyses performed using the OC data. In the OC data, no imputation was carried for any missing data.
Time frame
Week 12
Population
FAS1 Population. Only those participants available at the specified time points were analyzed.

Source ClinicalTrials.gov

Trial

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
Phases
PHASE3
Conditions
Parkinson Disease
Interventions
Ropinirole CR 2mg tablet, Ropinirole CR 8mg tablet, Ropinirole CR matching Placebo tablet
Lead sponsor
GlaxoSmithKline
Results first posted
2015-05-21

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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