Comparison · NCT01154166-eeaf1e05
Ropinirole PR vs Placebo: Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Ropinirole PR vs Placebo: Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF. Trial comparisons, record NCT01154166-eeaf1e05. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01154166-eeaf1e05
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.117 | 0.0697 | 0.19 | wilson | |
| Risk in group 2 | 0.359 | 0.253 | 0.482 | wilson | |
| Risk difference, group 1 minus group 2 | -0.242 | -0.374 | -0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.326 | 0.178 | 0.598 | log | |
| Odds ratio, group 1 over group 2 | 0.236 | 0.109 | 0.512 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ropinirole PR than on Placebo | 4.13 | 2.68 | 8.84 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ropinirole PR | Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR. | 13 | 111 | OG001 |
| Group 2 | Placebo | Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication. | 23 | 64 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Requiring Reinstatement of L-dopa Following a Dose Reduction Using LOCF
- Description
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.
- Time frame
- Week 24
- Population
- 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.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Parkinson Disease
- Interventions
- ReQuip PR, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-08-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01154166?tab=results
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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