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Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00321854
First received: May 3, 2006
Last updated: May 7, 2014
Last verified: March 2014
History of Changes
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Parkinson Disease
Intervention: Drug: pramipexole

  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
Early Pramipexole Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
Delayed Pramipexole Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.

Participant Flow:   Overall Study
    Early Pramipexole   Delayed Pramipexole
STARTED   261   274 
COMPLETED   198   192 
NOT COMPLETED   63   82 
Adverse Event                41                43 
Lack of Efficacy                9                14 
Protocol Violation                6                5 
Lost to Follow-up                0                2 
Withdrawal by Subject                6                17 
Other                1                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.
No text entered.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
Total Total of all reporting groups

Baseline Measures
   Early Pramipexole   Delayed Pramipexole   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 261   274   535 
Age [1] 
[Units: Years]
Mean (Standard Deviation) 		 62.1  (10.1)   62.9  (9.9)   62.5  (10) 
[1] Treated set (TS)
Gender [1] 
[Units: Participants]
 		     
Female   84   108   192 
Male   177   166   343 
[1] Treated set (TS)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]
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6.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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7.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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8.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9   [ Time Frame: Baseline and Month 9 ]
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9.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6   [ Time Frame: Baseline and Month 6 ]
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10.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3   [ Time Frame: Baseline and Month 3 ]
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11.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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12.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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13.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9   [ Time Frame: Baseline and Month 9 ]
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14.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6   [ Time Frame: Baseline and Month 6 ]
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15.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9   [ Time Frame: Baseline and Month 9 ]
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19.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6   [ Time Frame: Baseline and Month 6 ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3   [ Time Frame: Baseline and Month 3 ]
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21.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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23.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]
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24.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]
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25.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]
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26.  Secondary:   Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15   [ Time Frame: Month 15 ]
  Show Outcome Measure 26

27.  Secondary:   Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]
  Show Outcome Measure 29

30.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]
  Show Outcome Measure 30

31.  Secondary:   Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 32

33.  Secondary:   Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]
  Show Outcome Measure 33

34.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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35.  Secondary:   Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9   [ Time Frame: Baseline and Month 9 ]
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36.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15   [ Time Frame: Baseline and Month 15 ]
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37.  Secondary:   Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9   [ Time Frame: Baseline and Month 9 ]
  Show Outcome Measure 37

38.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1   [ Time Frame: Month 1 ]
  Hide Outcome Measure 38

Measure Type Secondary
Measure Title Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
Measure Description The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time Frame Month 1  

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.
The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.

Reporting Groups
  Description
Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months)
Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)

Measured Values
   Early Pramipexole   Delayed Pramipexole 
Participants Analyzed 
[Units: Participants]
 		 146   133 
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 
[Units: Participants]
 		   
No risk of gambling   146   133 
Risk of gambling   0   0 

No statistical analysis provided for Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1



39.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 39

40.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 40

41.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 41

42.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15   [ Time Frame: Month 15 ]
  Show Outcome Measure 42

43.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 43

44.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 44

45.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 45

46.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 46

47.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15   [ Time Frame: Month 15 ]
  Show Outcome Measure 47

48.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1   [ Time Frame: Month 1 ]
  Show Outcome Measure 48

49.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6   [ Time Frame: Month 6 ]
  Show Outcome Measure 49

50.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9   [ Time Frame: Month 9 ]
  Show Outcome Measure 50

51.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12   [ Time Frame: Month 12 ]
  Show Outcome Measure 51

52.  Secondary:   Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15   [ Time Frame: Month 15 ]
  Show Outcome Measure 52

53.  Secondary:   Percentage Change From Baseline in the Striatum Uptake at Month 15   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 53

54.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 54

55.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes   [ Time Frame: Baseline and Month 15 ]
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56.  Secondary:   Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 56

57.  Secondary:   Clinically Significant Abnormalities in Vital Signs   [ Time Frame: Baseline and Month 15 ]
  Show Outcome Measure 57


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00321854     History of Changes
Other Study ID Numbers: 248.595
Study First Received: May 3, 2006
Results First Received: December 18, 2009
Last Updated: May 7, 2014