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Trial record 5 of 28 for:    PARKINSON DISEASE 12

A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560508
First Posted: November 19, 2007
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
Results First Submitted: November 25, 2010  
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
Interventions: Drug: Pramipexole Immediate Release
Drug: Pramipexole Extended Release

  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 Extended Release Group (PPX ER) Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Pramipexole Immediate Release Group (PPX IR) Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day

Participant Flow for 2 periods

Period 1:   12 Week Double-blind Period
    Pramipexole Extended Release Group (PPX ER)   Pramipexole Immediate Release Group (PPX IR)
STARTED   56   56 
COMPLETED   51   53 
NOT COMPLETED   5   3 
Adverse Event                3                2 
Protocol Violation                1                0 
Withdrawal by Subject                1                1 

Period 2:   52-week Open-label Period Pramipexole ER
    Pramipexole Extended Release Group (PPX ER)   Pramipexole Immediate Release Group (PPX IR)
STARTED   51 [1]   53 [1] 
COMPLETED   43   42 
NOT COMPLETED   8   11 
Adverse Event                6                6 
Lack of Efficacy                1                1 
Withdrawal by Subject                0                3 
Other reason - investigator's judgement                1                1 
[1] all patients received Pramipexole ER for the 52-week open-label period



  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
Pramipexole Extended Release Group (PPX ER) Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
Pramipexole Immediate Release Group (PPX IR) Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
Total Total of all reporting groups

Baseline Measures
   Pramipexole Extended Release Group (PPX ER)   Pramipexole Immediate Release Group (PPX IR)   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   56   112 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.8  (8.0)   66.1  (7.5)   67.5  (7.8) 
Gender 
[Units: Participants]
     
Female   35   35   70 
Male   21   21   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Experienced Adverse Events   [ Time Frame: 12 weeks ]

2.  Secondary:   Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III Total Score   [ Time Frame: baseline and after 12 weeks treatment ]

3.  Secondary:   Change From Baseline in Percentage Off-time   [ Time Frame: baseline and after 12 weeks treatment ]

4.  Secondary:   Change From Baseline in Percentage On-time Without Dyskinesia   [ Time Frame: baseline and after 12 weeks treatment ]

5.  Secondary:   Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia   [ Time Frame: baseline and after 12 weeks treatment ]

6.  Secondary:   Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia   [ Time Frame: baseline and after 12 weeks treatment ]

7.  Secondary:   Change From Baseline in Percentage On-time With Troublesome Dyskinesia   [ Time Frame: baseline and after 12 weeks treatment ]

8.  Secondary:   Responder Rate For Clinical Global Impression of Improvement (CGI-I)   [ Time Frame: baseline and after 12 weeks treatment ]

9.  Secondary:   Responder Rate For Patient Global Impression of Improvement (PGI-I)   [ Time Frame: baseline and after 12 weeks treatment ]

10.  Secondary:   Change From Baseline in UPDRS Part I Score   [ Time Frame: baseline and after 12 weeks treatment ]

11.  Secondary:   Change From Baseline in UPDRS Part II Score   [ Time Frame: baseline and after 12 weeks treatment ]

12.  Secondary:   Change From Baseline in UPDRS Part III Score   [ Time Frame: baseline and after 12 weeks treatment ]

13.  Secondary:   Change From Baseline in UPDRS Part IV Score   [ Time Frame: baseline and after 12 weeks treatment ]

14.  Secondary:   UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement)   [ Time Frame: baseline and after 12 weeks treatment ]

15.  Secondary:   Change From Baseline in L-dopa Daily Dose   [ Time Frame: baseline and after 12 weeks treatment ]

16.  Secondary:   Trough Plasma Concentration at Steady State   [ Time Frame: at Visit 8 after pramipexole ER 4.5mg and IR 4.5mg treatment ]

17.  Secondary:   Dose Proportionality of Trough Plasma Concentration at Steady State After Pramipexole ER Treatment   [ Time Frame: from Visit 1 to Visit 8 after pramipexole ER ]

18.  Secondary:   Change From End of Double-Blind Period in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Dose Adjustment Phase)   [ Time Frame: Week 12 to Week 16 ]

19.  Secondary:   Percentage of Patients With no Worsening of UPDRS Parts II+III Total Score by More Than 15% From Week 12 to Week 16 (Open-label: Dose Adjustment Phase)   [ Time Frame: Week 12 to Week 16 ]

20.  Secondary:   Clinical Global Impression of Improvement (CGI-I) at Week 16 Compared to Patient's CGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)   [ Time Frame: Week 12 to Week 16 ]

21.  Secondary:   Patient Global Impression of Improvement (PGI-I) at Week 16 Compared to Patient's PGI-I Status at Week 12 (Open-label: Dose Adjustment Phase)   [ Time Frame: Week 12 to Week 16 ]

22.  Secondary:   Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Parts II+III Total Score (Open-label: Maintenance Phase)   [ Time Frame: Baseline and after 64 weeks treatment ]

23.  Secondary:   UPDRS Parts II+III Total Score Responder Rate (at Least 20% Improvement) (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

24.  Secondary:   Change From Baseline in Percentage Off-time (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

25.  Secondary:   Change From Baseline in Percentage On-time Without Dyskinesia (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

26.  Secondary:   Change From Baseline in Percentage On-time With Non-troublesome Dyskinesia (Open-label Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

27.  Secondary:   Change From Baseline in Percentage On-time Without Dyskinesia or With Non-troublesome Dyskinesia (Open-label Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

28.  Secondary:   Change From Baseline in Percentage On-time With Troublesome Dyskinesia (Open-label Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

29.  Secondary:   Change From Baseline in L-dopa Daily Dose (Open-label Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

30.  Secondary:   Change From Baseline in UPDRS Part I Score (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

31.  Secondary:   Change From Baseline in UPDRS Part II Score (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

32.  Secondary:   Change From Baseline in UPDRS Part III Score (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]

33.  Secondary:   Change From Baseline in UPDRS Part IV Score (Open-label: Maintenance Phase)   [ Time Frame: baseline and after 64 weeks treatment ]


  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



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00560508     History of Changes
Other Study ID Numbers: 248.610
First Submitted: November 16, 2007
First Posted: November 19, 2007
Results First Submitted: November 25, 2010
Results First Posted: February 10, 2011
Last Update Posted: July 31, 2014