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
Results First Received: September 30, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Parkinson Disease

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mirapexin® (Pramipexole)

The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.

mode of administration (admin.): Tablets for oral use


Participant Flow:   Overall Study
    Mirapexin® (Pramipexole)  
STARTED     2448  
COMPLETED     2335  
NOT COMPLETED     113  
Lack of Efficacy                 36  
Insufficient tolerability (IT)                 17  
Withdrawal by Subject                 18  
unknown                 32  
Lack of efficacy and patient wish                 1  
IT and patient wish                 8  
Patients wish and other reason                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Treated set (TS)

Reporting Groups
  Description
Mirapexin® (Pramipexole) The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.

Baseline Measures
    Mirapexin® (Pramipexole)  
Number of Participants  
[units: participants]
  2448  
Age  
[units: years]
Mean ( Full Range )
  67.23  
  ( 31 to 97 )  
Gender, Customized  
[units: participants]
 
Female     1145  
Male     1274  
missing     29  



  Outcome Measures
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1.  Primary:   Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated   [ Time Frame: 4 - 8 weeks ]

2.  Secondary:   Change From Baseline in UPDRS (Unified Parkinson’s Disease Rating Scale) Part I   [ Time Frame: Baseline and 4 to 8 weeks ]

3.  Secondary:   Change From Baseline in UPDRS Part III   [ Time Frame: Baseline and 4 - 8 weeks ]

4.  Secondary:   Global Clinical Assessments of Efficacy of Mirapexin® for All Patients   [ Time Frame: 4 - 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00802178     History of Changes
Other Study ID Numbers: 248.613
Study First Received: December 3, 2008
Results First Received: September 30, 2009
Last Updated: March 14, 2014
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
European Union: European Medicines Agency
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health