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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
Results First Received: December 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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 ]

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

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

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

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

6.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

7.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

8.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

9.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

10.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

11.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

12.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15   [ Time Frame: Baseline and Month 15 ]

13.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9   [ Time Frame: Baseline and Month 9 ]

14.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6   [ Time Frame: Baseline and Month 6 ]

15.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3   [ Time Frame: Baseline and Month 3 ]

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

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

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

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

20.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3   [ Time Frame: Baseline and Month 3 ]

21.  Secondary:   Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

22.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15   [ Time Frame: Baseline and Month 15 ]

23.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9   [ Time Frame: Baseline and Month 9 ]

24.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6   [ Time Frame: Baseline and Month 6 ]

25.  Secondary:   Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3   [ Time Frame: Baseline and Month 3 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame Onset date after the date of first dose up to 48 hours after last dose of study drug.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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)

Other Adverse Events
    Early Pramipexole   Delayed Pramipexole
Total, other (not including serious) adverse events     
# participants affected / at risk   172/261 (65.90%)   164/274 (59.85%) 
Gastrointestinal disorders     
Nausea † 1     
# participants affected / at risk   62/261 (23.75%)   49/274 (17.88%) 
Constipation † 1     
# participants affected / at risk   19/261 (7.28%)   28/274 (10.22%) 
Diarrhoea † 1     
# participants affected / at risk   10/261 (3.83%)   22/274 (8.03%) 
General disorders     
Fatigue † 1     
# participants affected / at risk   36/261 (13.79%)   38/274 (13.87%) 
Oedema peripheral † 1     
# participants affected / at risk   25/261 (9.58%)   13/274 (4.74%) 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   19/261 (7.28%)   24/274 (8.76%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   24/261 (9.20%)   18/274 (6.57%) 
Arthralgia † 1     
# participants affected / at risk   17/261 (6.51%)   6/274 (2.19%) 
Nervous system disorders     
Somnolence † 1     
# participants affected / at risk   36/261 (13.79%)   21/274 (7.66%) 
Dizziness † 1     
# participants affected / at risk   35/261 (13.41%)   33/274 (12.04%) 
Headache † 1     
# participants affected / at risk   20/261 (7.66%)   28/274 (10.22%) 
Psychiatric disorders     
Insomnia † 1     
# participants affected / at risk   26/261 (9.96%)   21/274 (7.66%) 
Depression † 1     
# participants affected / at risk   18/261 (6.90%)   16/274 (5.84%) 
Sleep disorder † 1     
# participants affected / at risk   14/261 (5.36%)   6/274 (2.19%) 
Abnormal dreams † 1     
# participants affected / at risk   8/261 (3.07%)   14/274 (5.11%) 
Vascular disorders     
Hypertension † 1     
# participants affected / at risk   11/261 (4.21%)   16/274 (5.84%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.0



  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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