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

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
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
Unknown	1	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.
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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
Number of Participants   [units: participants]	261	274	535
Age [1] [units: Years] Mean ± Standard Deviation	62.1  ± 10.1	62.9  ± 9.9	62.5  ± 10
Gender [1] [units: participants]
Female	84	108	192
Male	177	166	343

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 ]

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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