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A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early PD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00402233
First received: November 19, 2006
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
Results First Received: September 22, 2009  
Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment;   Primary Purpose: Treatment
Condition: Parkinson Disease
Interventions: Drug: Pramipexole
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 312 patients enrolled and 311 patients entered

Reporting Groups
  Description
Placebo No text entered.
Pramipexole 0.5 mg Tid Pramipexole 0.5 mg tid (three times a day)
Pramipexole 0.5 mg Bid Pramipexole 0.5 mg bid (bis in die (two times a day))
Pramipexole 0.75 mg Bid Pramipexole 0.75 mg bid (bis in die (two times a day))

Participant Flow:   Overall Study
    Placebo     Pramipexole 0.5 mg Tid     Pramipexole 0.5 mg Bid     Pramipexole 0.75 mg Bid  
STARTED     77     80     81     73  
COMPLETED     72     70     70     62  
NOT COMPLETED     5     10     11     11  
Adverse Event                 1                 7                 9                 9  
Protocol Violation                 0                 1                 0                 0  
Withdrawal by Subject                 2                 1                 2                 2  
Worsening of disease under study                 2                 0                 0                 0  
Worsening of other pre-existing disease                 0                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo No text entered.
Pramipexole 0.5 mg Tid No text entered.
Pramipexole 0.5 mg Bid No text entered.
Pramipexole 0.75 mg Bid No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     Pramipexole 0.5 mg Tid     Pramipexole 0.5 mg Bid     Pramipexole 0.75 mg Bid     Total  
Number of Participants  
[units: participants]
 		  77     80     81     73     311  
Age  
[units: years]
Mean ± Standard Deviation 		  60.7  ± 11     63.7  ± 9.8     61.6  ± 10.2     63.1  ± 9.9     62.3  ± 10.2  
Gender  
[units: participants]
 		         
Female     19     23     30     32     104  
Male     58     57     51     41     207  



  Outcome Measures
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1.  Primary:   Unified Parkinson's Disease Rating Scale (UPDRS) Total Score   [ Time Frame: From baseline to week 12 ]
  Show Outcome Measure 1

2.  Secondary:   Modified Hoehn and Yahr Stage   [ Time Frame: From baseline to week 12 ]
  Show Outcome Measure 2

3.  Secondary:   Epworth Sleepiness Scale   [ Time Frame: From baseline to week 12 ]
  Show Outcome Measure 3

4.  Secondary:   Beck Depression Inventory II   [ Time Frame: From baseline to week 12 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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: NCT00402233     History of Changes
Other Study ID Numbers: 248.622, PramiBID
Study First Received: November 19, 2006
Results First Received: September 22, 2009
Last Updated: May 18, 2012
Health Authority: United States: Food and Drug Administration