Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice
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|ClinicalTrials.gov Identifier: NCT01061567|
Recruitment Status : Completed
First Posted : February 3, 2010
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1814 participants|
|Official Title:||Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice|
|Study Start Date :||November 2009|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
|Male and female patients with Parkinson's disease|
- Incidence of Adverse Events [ Time Frame: 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. [ Time Frame: 16 weeks ]Patients who discontinued treatment due to adverse events including deaths.
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061567
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|