Trial · NCT01191944
Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
NCT01191944, Phase 3, Completed, Boehringer Ingelheim; results first posted 2013-01-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients. Trials, record NCT01191944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191944
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients
- NCT number
- NCT01191944
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 475 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- pramipexole immediate release tablet, pramipexole extended release tablet
- First posted
- 2010-08-31
- Last updated
- 2014-10-31
- Results first posted
- 2013-01-24
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 | Baseline and week 18 | UPDRS total score ranges from 0 (best) to 160 (worst) and was calculated as the sum of Part II (activities of daily living, ranges from 0 to 52) and Part III (motor examination, ranges from 0 to 108). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | Percentage off-time during waking hours based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Duration of Off-time During Waking Hours at Week 18 | Baseline and week 18 | Duration of off-time during waking hours based on patient diary data. Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Responder in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | Percentage off-time based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). Off-time describes a period when the patient experiences increased parkinsonian symptoms (e.g. immobility or inability to move with ease). Reduction over time represents an improvement. Responders were defined as patients with at least a 20 percent improvement relative to baseline. |
| Secondary | Change From Baseline in Percentage On-time Without Dyskinesia at Week 18 | Baseline and week 18 | Percentage on-time without Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | Percentage on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | Percentage on-time without or with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18 | Baseline and week 18 | Percentage on-time with troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (best case) to 100 (worst case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as troublesome if it interfered with function or caused meaningful discomfort. Decrease in the percentage represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Duration of On-time Without Dyskinesia at Week 18 | Baseline and week 18 | Duration of on-time without Dyskinesia based on patient diary data. On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. |
| Secondary | Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | Duration on-time with non-troublesome Dyskinesia based on patient diary data, percentage ranging from 0 (worst case) to 100 (best case). On-time describes a period during which a patient was relatively free of Parkinsons symptoms (e.g. mobile or capable of moving with relative ease and independence). Dyskinesia qualified as non-troublesome if it did not interfere with function or did not cause meaningful discomfort. Increase in the duration represents an improvement. Means are adjusted for treatment, centre and baseline. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 | Baseline and week 18 | Full analysis set (FAS) with last observation carried forward (LOCF). FAS is defined as all randomised patients which received at least one dose of study drug and provided any post baseline efficacy assessment. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced Parkinsons Disease (PD). Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage off-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Responder in Percentage Off-time During Waking Hours at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Percentage On-time Without Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time Without or With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Percentage On-time With Troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | Percentage of on-time | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time Without Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Duration of On-time With Non-troublesome Dyskinesia at Week 18 | Baseline and week 18 | FAS (LOCF) reduced to patients with advanced PD. Advanced PD patients were those reporting at least 2 hours of off-time daily during each of the two days before baseline, as recorded in the patient diary. | hours | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 | Pramipexole ER | -13.807 | Standard Error 0.6547 | Units on a scale | |
| Change From Baseline in Unified Parkinsons Disease Rating Scale (UPDRS) Parts II+III Score at Week 18 | Pramipexole IR | -13.047 | Standard Error 0.6434 | Units on a scale | |
| Change From Baseline in Percentage Off-time During Waking Hours at Week 18 | Pramipexole ER | -6.962 | Standard Error 1.5072 | Percentage off-time | |
| Change From Baseline in Percentage Off-time During Waking Hours at Week 18 | Pramipexole IR | -7.443 | Standard Error 1.5362 | Percentage off-time | |
| Change From Baseline in Duration of Off-time During Waking Hours at Week 18 | Pramipexole ER | -1.044 | Standard Error 0.2256 | hours | |
| Change From Baseline in Duration of Off-time During Waking Hours at Week 18 | Pramipexole IR | -1.098 | Standard Error 0.2300 | hours | |
| Responder in Percentage Off-time During Waking Hours at Week 18 | Pramipexole ER | Responder | 58 | Participants | |
| Responder in Percentage Off-time During Waking Hours at Week 18 | Pramipexole IR | Responder | 59 | Participants | |
| Responder in Percentage Off-time During Waking Hours at Week 18 | Pramipexole ER | Non-Responder | 52 | Participants | |
| Responder in Percentage Off-time During Waking Hours at Week 18 | Pramipexole IR | Non-Responder | 47 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pramipexole ER | 234 | |
| Overall Study | STARTED | Pramipexole IR | 239 | |
| Overall Study | COMPLETED | Pramipexole ER | 217 | |
| Overall Study | COMPLETED | Pramipexole IR | 220 | |
| Overall Study | NOT COMPLETED | Pramipexole ER | 17 | |
| Overall Study | NOT COMPLETED | Pramipexole IR | 19 |
Source ClinicalTrials.gov
Adverse events48
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 | Constipation | Gastrointestinal disorders | Pramipexole ER | 17 | 234 | |
| other | Constipation | Gastrointestinal disorders | Pramipexole IR | 20 | 239 | |
| other | Nausea | Gastrointestinal disorders | Pramipexole ER | 20 | 234 | |
| other | Nausea | Gastrointestinal disorders | Pramipexole IR | 17 | 239 | |
| other | Dizziness | Nervous system disorders | Pramipexole ER | 30 | 234 | |
| other | Dizziness | Nervous system disorders | Pramipexole IR | 31 | 239 | |
| other | Dyskinesia | Nervous system disorders | Pramipexole ER | 12 | 234 | |
| other | Dyskinesia | Nervous system disorders | Pramipexole IR | 18 | 239 | |
| other | Somnolence | Nervous system disorders | Pramipexole ER | 51 | 234 | |
| other | Somnolence | Nervous system disorders | Pramipexole IR | 35 | 239 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pramipexole ER | ||
| Total, all-cause mortality | Pramipexole IR | ||
| Total, other adverse events | Pramipexole ER | 93 | 234 |
| Total, other adverse events | Pramipexole IR | 90 | 239 |
| Total, serious adverse events | Pramipexole ER | 6 | 234 |
| Total, serious adverse events | Pramipexole IR | 13 | 239 |
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 |
|---|
| Pramipexole ER vs Pramipexole IR: 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.
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