An observational study in Parkinson's Disease, sponsored by Boehringer Ingelheim. Completed at 284 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-08.
Sponsored by Boehringer Ingelheim · Observational
The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 1,814 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients
Exclusion criteria:
In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.
Incidence of Adverse Events
The number of patients with any adverse events (AEs), patients with drug-related AEs.
Time frame: From the treatment initiation to the end of study, on average 92.9 days
Proportion of Patients With Withdrawals Due to Adverse Events.
Patients who discontinued treatment due to adverse events including deaths.
Time frame: 16 weeks
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement.
Time frame: Baseline and the end of study (up to 16 weeks)
Clinical Global Impression of Improvement (CGI-I) Responder Rate
The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
Time frame: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction.
Time frame: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement
Time frame: Baseline and the end of study (up to 16 weeks)
| Milestone | All Patients |
|---|---|
| Started | 1814 |
| Completed | 1738 |
| Not completed | 76 |
| Withdrew: Adverse event | 32 |
| Withdrew: Death | 2 |
| Withdrew: Lack of efficacy | 3 |
| Withdrew: Lost to follow-up | 24 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Other reason than stated above | 3 |
The number of patients with any adverse events (AEs), patients with drug-related AEs.
| participants | All Patients |
|---|---|
| Patients with any AE | 105 |
| Patients with drug-related AEs | 56 |
Patients who discontinued treatment due to adverse events including deaths.
| proportion of participants | All Patients |
|---|---|
| Proportion of Patients With Withdrawals Due to Adverse Events. | 0.019 |
Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change\>0) in the score means improvement.
| units on a scale | All Patients |
|---|---|
| UPDRS Part I score (N=1756) | 1.1 ± 1.6 |
| UPDRS Part III score (N=1670) | 10.6 ± 9.4 |
The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
| percentage of participants | All Patients |
|---|---|
| Clinical Global Impression of Improvement (CGI-I) Responder Rate | 84.3 |
The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change\>0) reflects an improvement in patient satisfaction.
| units on a scale | All Patients |
|---|---|
| Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction | 18.5 ± 22.6 |
The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change \>0 reflects an improvement
| units on a scale | All Patients |
|---|---|
| Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score | 0.6 ± 1.1 |
Collected over From the treatment initiation to the end of study, on average 92.9 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Patients | — | 4/1,814 (0.2%) | 0/1,814 (0%) |
| Event | All Patients |
|---|---|
| Cerebral insultNervous system disorders | 1/1814 |
| GamblingPsychiatric disorders | 1/1814 |
| AspirationRespiratory, thoracic and mediastinal disorders | 1/1814 |
| Heart failureVascular disorders | 1/1814 |
Patients from Treated Set (TS) who were documented to have taken at least one dose of study treatment.
| Age, Continuous(years) | All Patients |
|---|---|
| Mean | 68.8 ± 9.2 |
| Gender(participants) | All Patients |
|---|---|
| Female | 910 |
| Male | 889 |
Showing the first 100 of 284 sites across 7 countries.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim