First Presentation of Parkinson Disease Patients to Neurologist

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00802178
First received: December 3, 2008
Last updated: March 14, 2014
Last verified: March 2014

December 3, 2008
March 14, 2014
February 2006
September 2007   (final data collection date for primary outcome measure)
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]

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)

To determine the main reasons for pramipexole treatment
Complete list of historical versions of study NCT00802178 on ClinicalTrials.gov Archive Site
  • Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I [ Time Frame: Baseline and 4 to 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Referral patterns for PD patients [ Time Frame: 4 to 8 weeks ]
  • Prescribing patterns for PD patients [ Time Frame: 4 to 8 weeks ]
  • Time pattern and frequency of PD symptoms [ Time Frame: 4 to 8 weeks ]
  • Reasons and frequency of pramipexole discontinuation [ Time Frame: 4 to 8 weeks ]
  • Change in UPDRS I and III score from baseline to after treatment [ Time Frame: 4 to 8 weeks ]
Not Provided
Not Provided
 
First Presentation of Parkinson Disease Patients to Neurologist
CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients

In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

neurogologists

Parkinson Disease
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2448
Not Provided
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Parkinson Disease patients presenting to neurologist for first time

Exclusion Criteria:

- Hypersensitivity to the active substance or to any of the excipients

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Croatia,   Czech Republic,   Estonia,   Hungary,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia
 
NCT00802178
248.613
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP