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Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00615914
First received: January 31, 2008
Last updated: June 10, 2014
Last verified: June 2014
Results First Received: September 8, 2010  
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pramipexole Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)

Participant Flow:   Overall Study
    Pramipexole  
STARTED     1645 [1]
COMPLETED     1008  
NOT COMPLETED     637  
Adverse Event                 274  
Death                 20  
Lack of Efficacy                 59  
Lost to Follow-up                 187  
Withdrawal by Subject                 16  
Physician Decision                 4  
No data was collected.                 65  
No treatment                 2  
Irregularly enrolled patients                 10  
[1] The number of patients enrolled



  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.
Data set for safety analysis - The number of patients enrolled was 1645. The number of case report forms which were collected was 1581. Moreover the number of patients analyzed as safety analysis was 1553 because 28 patients were excluded due to protocol violations.

Reporting Groups
  Description
Pramipexole Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).

Baseline Measures
    Pramipexole  
Number of Participants  
[units: participants]
  1553  
Age  
[units: years]
Mean ± Standard Deviation
  69.0  ± 8.9  
Gender  
[units: participants]
 
Female     890  
Male     663  



  Outcome Measures
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1.  Primary:   Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events   [ Time Frame: during 18 months ]

2.  Secondary:   Clinical Global Impression of Improvement   [ Time Frame: 18 months ]

3.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score   [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]

4.  Secondary:   Change From Baseline in Modified Hoehn & Yahr Rating Scale   [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


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: NCT00615914     History of Changes
Other Study ID Numbers: 248.547
Study First Received: January 31, 2008
Results First Received: September 8, 2010
Last Updated: June 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare