Trial · NCT01525641
Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
NCT01525641, Completed, Boehringer Ingelheim; results first posted 2015-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease. Trials, record NCT01525641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01525641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's Disease
- NCT number
- NCT01525641
- Status
- Completed
- Enrollment
- 615 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Parkinson Disease
- Interventions
- Mirapex LA
- First posted
- 2012-02-03
- Last updated
- 2015-08-14
- Results first posted
- 2015-08-14
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Adverse Drug Reactions | From baseline up to week 52 | Percentage of subjects with adverse drug reactions |
| Secondary | Clinical Global Impression of Effect | Week 52 | Clinical global impression (CGI) of effect at the last observation, on a rating scale from very much improved to no effect. |
| Secondary | Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Baseline and week 52 | Change from baseline at the last observation in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III total score. UPDRS Part III (motor examination) measures the extent of physical impairment displayed by the patient. This evaluation consists of 14 separate components of patient's physical status. The UPDRS part III score is the sum of the 14 individual components. The UPDRS Part III total score ranges from 0 to 108.A reduction in UPDRS part III score over time corresponds to an improvement in motor activities. The following are the 14 separate components:1. Speech 2. Facial expression 3. Tremor at rest 4. Action or postural tremor of hands 5. Rigidity 6. Finger taps 7. Hand movements 8. Rapid alternating movements of hands 9. Leg agility 10. Arising from chair 11. Posture 12. Gait 13. Postural stability 14. Body bradykinesia and hypokinesia. |
| Secondary | Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Baseline and week 52 | Change from baseline at the last observation in the modified Hoehn and Yahr stage. Stages of the Parkinson's disease will be assessed on an 8-degree scale between stage 0 (no sign of the disease) and 5 (wheelchair bound or bedridden unless aided) in steps of 0, 1, 1.5, 2, 2.5, 3, 4 and 5. A reduction in the score over time represents an improvement. |
| Secondary | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Number of patients with onset or offset of on-off phenomenon in patients with concomitant levodopa (L-DOPA). On-off phenomenon is the unpredictable shift from mobility - "on" - to a sudden inability to move - "off". |
| Secondary | Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Number of patients with onset or offset of wearing-off phenomena in patients with concomitant levodopa (L-DOPA). Wearing-off is when Parkinson's symptoms begin to reappear or become noticeably worse before it is time to take the next scheduled dose of medication. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Adverse Drug Reactions | From baseline up to week 52 | Safety set | percentage of participants | NUMBER |
| SECONDARY | Clinical Global Impression of Effect | Week 52 | Efficacy set: included all patients in the safety set except those who had no available efficacy data and/or who did not suffer from Parkinsons Disease | participants | NUMBER |
| SECONDARY | Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Baseline and week 52 | Efficacy set | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Baseline and week 52 | Efficacy set | Units on a scale | MEAN |
| SECONDARY | Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Patients in safety set and with concomitant L-DOPA. | participants | NUMBER |
| SECONDARY | Onset or Offset of Wearing-off Phenomenon in Patients With Concomitant L-DOPA | Week 52 | Patients in safety set and with concomitant L-DOPA | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Adverse Drug Reactions | Subjects With Parkinson's Disease (PD) | 24.78 | percentage of participants | ||
| Clinical Global Impression of Effect | Subjects With Parkinson's Disease (PD) | Very much improved | 14 | participants | |
| Clinical Global Impression of Effect | Subjects With Parkinson's Disease (PD) | Much improved | 223 | participants | |
| Clinical Global Impression of Effect | Subjects With Parkinson's Disease (PD) | Minimally improved | 205 | participants | |
| Clinical Global Impression of Effect | Subjects With Parkinson's Disease (PD) | No effect | 67 | participants | |
| Change From Baseline in Total Score of the UPDRS Part III to Last Observation | Subjects With Parkinson's Disease (PD) | -3.73 | Standard Deviation 8.27 | units on a scale | |
| Change From Baseline in the Modified Hoehn & Yahr to Last Observation | Subjects With Parkinson's Disease (PD) | -0.12 | Standard Deviation 0.40 | Units on a scale | |
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Subjects With Parkinson's Disease (PD) | Yes | 43 | participants | |
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Subjects With Parkinson's Disease (PD) | No | 262 | participants | |
| Onset or Offset of On and Off Phenomenon in Patients With Concomitant L-DOPA | Subjects With Parkinson's Disease (PD) | Unknown | 2 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Subjects With Parkinson's Disease (PD) | 615 | |
| Overall Study | COMPLETED | Subjects With Parkinson's Disease (PD) | 435 | |
| Overall Study | NOT COMPLETED | Subjects With Parkinson's Disease (PD) | 180 |
Source ClinicalTrials.gov
Adverse events36
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 | Somnolence | Nervous system disorders | Subjects With Parkinson's Disease (PD) | 35 | 569 | |
| serious | Anaemia | Blood and lymphatic system disorders | Subjects With Parkinson's Disease (PD) | 2 | 569 | |
| serious | Cardio-respiratory arrest | Cardiac disorders | Subjects With Parkinson's Disease (PD) | 2 | 569 | |
| serious | Constipation | Gastrointestinal disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Gastric ulcer haemorrhage | Gastrointestinal disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Gastritis erosive | Gastrointestinal disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Ileus | Gastrointestinal disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Melaena | Gastrointestinal disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Death | General disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 | |
| serious | Gait disturbance | General disorders | Subjects With Parkinson's Disease (PD) | 1 | 569 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Subjects With Parkinson's Disease (PD) | ||
| Total, other adverse events | Subjects With Parkinson's Disease (PD) | 35 | 569 |
| Total, serious adverse events | Subjects With Parkinson's Disease (PD) | 30 | 569 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01525641
GET https://conductscience.org/api/trials/v1/NCT01525641/events?page=2