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Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00144300
First Posted: September 5, 2005
Last Update Posted: March 14, 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: September 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Parkinson Disease
Interventions: Drug: Mirapex
Drug: Requip

  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
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Reporting Groups
  Description
Pramipexole Flexible: 0.125 mg 3 times daily up to maximum tolerated
Ropinirole Flexible: 0.25 mg 3 times daily up to maximum tolerated

Participant Flow:   Overall Study
    Pramipexole   Ropinirole
STARTED   121   125 
COMPLETED   92   97 
NOT COMPLETED   29   28 
Adverse Event                18                16 
Protocol Violation                1                3 
Lost to Follow-up                3                0 
Withdrawal by Subject                6                6 
Other reason (not specified)                1                3 



  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 Flexible: 0.125 mg 3 times daily up to maximum tolerated
Ropinirole Flexible: 0.25 mg 3 times daily up to maximum tolerated
Total Total of all reporting groups

Baseline Measures
   Pramipexole   Ropinirole   Total 
Overall Participants Analyzed 
[Units: Participants]
 121   125   246 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (9.3)   59.1  (8.7)   58.3  (9.0) 
Age, Customized 
[Units: Participants]
     
< 50 years   23   17   40 
50 to < 65 years   71   74   145 
65 to < 75 years   21   30   51 
>= 75 years   6   4   10 
Gender 
[Units: Participants]
     
Female   42   47   89 
Male   79   78   157 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   1   1   2 
Black   7   3   10 
White   113   121   234 
Height [1] 
[Units: Centimeters]
Mean (Standard Deviation)
 171.3  (9.2)   171.6  (12.4)   171.5  (10.9) 
[1] Measurements collected for 120, 125 participants in Pramipexole, Ropinirole respectively
Weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
 81.32  (17.64)   82.80  (18.39)   82.07  (18.00) 
[1] Measurements collected for 119, 122 participants in Pramipexole, Ropinirole respectively
Duration of Parkinson's disease diagnosis 
[Units: Years]
Mean (Standard Deviation)
 0.97  (1.15)   1.29  (1.70)   1.13  (1.46) 
Hoehn and Yahr stage [1] 
[Units: Participants]
     
Stage 0   0   0   0 
Stage 1   28   23   51 
Stage 1.5   11   19   30 
Stage 2   71   71   142 
Stage 2.5   8   5   13 
Stage 3   3   7   10 
Stage 4   0   0   0 
Stage 5   0   0   0 
[1] This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
Alcohol history 
[Units: Participants]
     
Does not drink   46   49   95 
Has an average consumption   75   76   151 
Fulfills criteria for Abuse/Dependence   0   0   0 


  Outcome Measures
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1.  Primary:   Expert Panel Overall Assessment Following 2 Years on Drug   [ Time Frame: up to 2 years ]

2.  Secondary:   Expert Panel Overall Assessment Following 1 Year on Drug   [ Time Frame: up to 1 years ]

3.  Secondary:   Hoehn and Yahr Scale at Baseline   [ Time Frame: Baseline ]

4.  Secondary:   Hoehn and Yahr Scale at 1 Year   [ Time Frame: Up to 1 year ]

5.  Secondary:   Hoehn and Yahr Scale at 2 Years   [ Time Frame: Up to 2 years ]

6.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline   [ Time Frame: Baseline ]

7.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year   [ Time Frame: 1 year ]

8.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year   [ Time Frame: Baseline, 1 year ]

9.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years   [ Time Frame: 2 years ]

10.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years   [ Time Frame: Baseline, 2 year ]

11.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline   [ Time Frame: Baseline ]

12.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year   [ Time Frame: 1 year ]

13.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year   [ Time Frame: Baseline, 1 year ]

14.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years   [ Time Frame: 2 years ]

15.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years   [ Time Frame: Baseline, 2 year ]

16.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline   [ Time Frame: Baseline ]

17.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year   [ Time Frame: 1 year ]

18.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year   [ Time Frame: Baseline, 1 year ]

19.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years   [ Time Frame: 2 years ]

20.  Secondary:   Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years   [ Time Frame: Baseline, 2 year ]

21.  Secondary:   Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs   [ Time Frame: Screen (Baseline) and final visit (24 months) ]


  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


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144300     History of Changes
Other Study ID Numbers: 248.538
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: September 16, 2011
Results First Posted: November 4, 2011
Last Update Posted: March 14, 2014