Trial · NCT01536574
Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
NCT01536574, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-12-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528. Trials, record NCT01536574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01536574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528
- NCT number
- NCT01536574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 295 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Parkinson Disease
- Interventions
- Requip PR
- First posted
- 2012-02-22
- Last updated
- 2018-08-13
- Results first posted
- 2012-12-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | From the start of treatment (Baseline) up to Week 25 | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. |
| Primary | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | From the start of treatment (Baseline) up to Week 25 | An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase. |
| Primary | Number of Participants With an Adverse Event During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition. |
| Primary | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. |
| Primary | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase. |
| Secondary | Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. |
| Secondary | Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | Baseline and Week 24 | The G-SAS is a reliable and valid self-reported measure of gambling symptoms. It is comprised of twelve questions aimed at evaluating gambling symptoms; each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48, where 0=least severe and 48=most severe. Change from Baseline is calculated as the value at Week 24 minus the Baseline value. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | From the start of treatment (Baseline) up to Week 25 | Safety Population: all participants who received at least one dose of study drug | Participants | NUMBER |
| PRIMARY | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase | From the start of treatment (Baseline) up to Week 25 | Safety Population | Participants | NUMBER |
| PRIMARY | Number of Participants With an Adverse Event During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | Safety Population | Participants | NUMBER |
| PRIMARY | Number of Participants With the Indicated Adverse Events During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | Safety Population | Participants | NUMBER |
| PRIMARY | Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase | 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | Safety Population | Participants | NUMBER |
| SECONDARY | Mean Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | Week 24 | Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points. | Scores on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in the Gambling Symptom Assessment Scale (G-SAS) Score at Week 24 | Baseline and Week 24 | Safety Population. Only those participants contributing data at the indicated time points were analyzed. Data were collected using the LOCF method. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Any AE | 58 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Placebo in Parent DB Study, Ropinirole PR in OL Study | Any AE | 56 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | AE Related to Investigational Product (IP) | 33 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Placebo in Parent DB Study, Ropinirole PR in OL Study | AE Related to Investigational Product (IP) | 35 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | Any SAE | 2 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Placebo in Parent DB Study, Ropinirole PR in OL Study | Any SAE | 4 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | SAE Related to Investigational Product (IP) | 0 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Placebo in Parent DB Study, Ropinirole PR in OL Study | SAE Related to Investigational Product (IP) | 1 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | AE Leading to Death | 0 | Participants | |
Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase) | Placebo in Parent DB Study, Ropinirole PR in OL Study | AE Leading to Death | 0 | Participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 162 | |
| Overall Study | STARTED | Placebo in Parent DB Study, Ropinirole PR in OL Study | 133 | |
| Overall Study | COMPLETED | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 156 | |
| Overall Study | COMPLETED | Placebo in Parent DB Study, Ropinirole PR in OL Study | 126 | |
| Overall Study | NOT COMPLETED | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 6 | |
| Overall Study | NOT COMPLETED | Placebo in Parent DB Study, Ropinirole PR in OL Study | 7 |
Source ClinicalTrials.gov
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 | Events |
|---|---|---|---|---|---|---|
| other | Dyskinesia | Nervous system disorders | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 7 | 162 | |
| other | Dyskinesia | Nervous system disorders | Placebo in Parent DB Study, Ropinirole PR in OL Study | 11 | 133 | |
| other | Dizziness | Nervous system disorders | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 7 | 162 | |
| other | Dizziness | Nervous system disorders | Placebo in Parent DB Study, Ropinirole PR in OL Study | 5 | 133 | |
| other | Somnolence | Nervous system disorders | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 2 | 162 | |
| other | Somnolence | Nervous system disorders | Placebo in Parent DB Study, Ropinirole PR in OL Study | 6 | 133 | |
| other | Headache | Nervous system disorders | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 0 | 162 | |
| other | Headache | Nervous system disorders | Placebo in Parent DB Study, Ropinirole PR in OL Study | 2 | 133 | |
| other | Hypoaesthesia | Nervous system disorders | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 1 | 162 | |
| other | Hypoaesthesia | Nervous system disorders | Placebo in Parent DB Study, Ropinirole PR in OL Study | 1 | 133 |
1 to 10 of 196Source ClinicalTrials.gov
See all 196 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | ||
| Total, all-cause mortality | Placebo in Parent DB Study, Ropinirole PR in OL Study | ||
| Total, other adverse events | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 58 | 162 |
| Total, other adverse events | Placebo in Parent DB Study, Ropinirole PR in OL Study | 56 | 133 |
| Total, serious adverse events | Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study | 2 | 162 |
| Total, serious adverse events | Placebo in Parent DB Study, Ropinirole PR in OL Study | 4 | 133 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25586298 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study vs Placebo in Parent DB Study, Ropinirole PR in OL Study: 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/NCT01536574
GET https://conductscience.org/api/trials/v1/NCT01536574/results?page=2