Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice
- Conditions
- Parkinson's Disease
- Registration Number
- NCT01061567
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1814
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events From the treatment initiation to the end of study, on average 92.9 days The number of patients with any adverse events (AEs), patients with drug-related AEs.
Proportion of Patients With Withdrawals Due to Adverse Events. 16 weeks Patients who discontinued treatment due to adverse events including deaths.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score Baseline and the end of study (up to 16 weeks) 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
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score Baseline and the end of study (up to 16 weeks) 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.
Clinical Global Impression of Improvement (CGI-I) Responder Rate Baseline and the end of study (up to 16 weeks) 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.
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction Baseline and the end of study (up to 16 weeks) 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.
Trial Locations
- Locations (284)
Boehringer Ingelheim Investigational Site 1
🇦🇹Bad Ischl, Austria
Boehringer Ingelheim Investigational Site 2
🇦🇹Bad Radkersburg, Austria
Boehringer Ingelheim Investigational Site 3
🇦🇹Baden, Austria
Boehringer Ingelheim Investigational Site 4
🇦🇹Baden, Austria
Boehringer Ingelheim Investigational Site 5
🇦🇹Bludenz, Austria
Boehringer Ingelheim Investigational Site 6
🇦🇹Braunau/Inn, Austria
Boehringer Ingelheim Investigational Site 7
🇦🇹Deutschlandsberg, Austria
Boehringer Ingelheim Investigational Site 8
🇦🇹Dornbirn, Austria
Boehringer Ingelheim Investigational Site 9
🇦🇹Dornbirn, Austria
Boehringer Ingelheim Investigational Site 10
🇦🇹Ehenbichl, Austria
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