First Presentation of Parkinson Disease Patients to Neurologist
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00802178|
Recruitment Status : Completed
First Posted : December 4, 2008
Results First Posted : November 20, 2009
Last Update Posted : April 11, 2014
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||2448 participants|
|Official Title:||CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2007|
- Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated [ Time Frame: 4 - 8 weeks ]
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
De-novo patients were identified by:
those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)
- Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I [ Time Frame: Baseline and 4 to 8 weeks ]Change in UPDRS Part I score from baseline to final visit. The score ranging from 0-16 (0= no disability, 16= maximum disability)
- Change From Baseline in UPDRS Part III [ Time Frame: Baseline and 4 - 8 weeks ]Change in UPDRS Part III score from baseline to final visit. Score ranging from 0 - 108 (0= no disability, 108 = worst disability).
- Global Clinical Assessments of Efficacy of Mirapexin® for All Patients [ Time Frame: 4 - 8 weeks ]Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor.
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): NCT00802178
Show 311 Study Locations
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|