Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

This study has been completed.

Study NCT00144300 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on September 2, 2005. Last Updated on November 2, 2011 History of Changes

Results First Received: September 16, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: 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
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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
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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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

Baseline Measures

	Pramipexole	Ropinirole	Total
Number of Participants [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
Weight ^[2] [units: kilograms] Mean ± Standard Deviation	81.32 ± 17.64	82.80 ± 18.39	82.07 ± 18.00
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 ^[3] [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
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

[1]	Measurements collected for 120, 125 participants in Pramipexole, Ropinirole respectively
[2]	Measurements collected for 119, 122 participants in Pramipexole, Ropinirole respectively
[3]	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)

Outcome Measures

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1. Primary:

Expert Panel Overall Assessment Following 2 Years on Drug [ Time Frame: up to 2 years ]

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2. Secondary:

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

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3. Secondary:

Hoehn and Yahr Scale at Baseline [ Time Frame: Baseline ]

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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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 ]

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9. Secondary:

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

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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 ]

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11. Secondary:

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

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12. Secondary:

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

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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 ]

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14. Secondary:

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

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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 ]

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16. Secondary:

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

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17. Secondary:

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

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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 ]

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19. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Other - Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

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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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

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00144300 History of Changes
Other Study ID Numbers:	248.538
Study First Received:	September 2, 2005
Results First Received:	September 16, 2011
Last Updated:	November 2, 2011
Health Authority:	United States: Food and Drug Administration