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

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00144300
• Collaborator: (none)
• Enrollment: 246
• Locations: 21
• Arms: 2
• Patients Per Site: 11.7

Study Details

Study Description

Brief Summary

To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Mirapex; Drug: Requip	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 246 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mirapex Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines	Drug: Mirapex; Standard marketed product dispensed according to manufacturer's guidelines
Active Comparator: Requip Requip tablets three times daily (TID) dosing according to manufacturer's guidelines	Drug: Requip; Standard marketed product dispensed according to manufacturer's guidelines

Outcome Measures

Primary Outcome Measures

1. Expert Panel Overall Assessment Following 2 Years on Drug [up to 2 years]

   Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments

Secondary Outcome Measures

1. Expert Panel Overall Assessment Following 1 Year on Drug [up to 1 years]

   Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments

2. Hoehn and Yahr Scale at Baseline [Baseline]

   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)

3. Hoehn and Yahr Scale at 1 Year [Up to 1 year]

   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)

4. Hoehn and Yahr Scale at 2 Years [Up to 2 years]

   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)

5. Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline [Baseline]

   Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

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

   Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

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

   Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

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

   Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

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

   Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.

10. Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline [Baseline]

    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.

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

    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.

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

    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.

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

    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.

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

    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.

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

    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).

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

    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).

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

    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).

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

    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).

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

    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).

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

    Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

Diagnosis and main criteria for inclusion. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Patients with idiopathic Parkinson's disease of less than 7 years characterized as Stage I-III by the Modified Hoehn and Yahr Scale and with a maximum of 6 months cumulative lifetime exposure to levodopa and/or dopamine agonist. Patients on current dopamine agonist therapy would require 14-day washout.

2. Age at least 30 years.

3. Women of childbearing potential must have a negative serum beta-HCG pregnancy test at the Screen (Baseline) visit and the patient must use adequate contraceptive methods.

4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

5. Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.

Exclusion criteria

Main criteria for exclusion. The presence of any of the following would make a patient ineligible for enrollment into the study:

1. Previous history of allergic response or complications with any dopaminergic agonist drug

2. Atypical PD syndromes

3. History of stereotactic brain surgery

4. Positive hepatitis B (surface antigen) or hepatitis C (antibody)

5. Surgery within 180 days of randomization which would negatively impact participation

6. Folstein's Mini Mental State Examination (MMSE) score of 24 or less

7. History of active epilepsy (seizure) in the past 1 year

8. Third degree AV block or sick sinus syndrome

9. Congestive heart failure, Class III or IV

10. Unstable heart disease such as unstable angina, dysrhythmia, or myocardial infarction in prior 6 months

11. Symptomatic orthostatic hypotension

12. Clinically significant liver disease or renal disease

13. Malignant melanoma or history of previously treated malignant melanoma.

14. Prohibited medications taken (including any drug known to have potential retino-toxic effects taken in the prior 12 months; neuroleptics taken within prior 6 months, MAO inhibitors except rasagiline or selegiline taken within prior 3 months, beta-blockers taken to treat Parkinson's disease in the prior 30 days, and Coenzyme Q10 taken within 14 days)

15. Albinism/Albinoidism of any degree, type or syndrome

16. History of glaucoma with or without treatment

17. Inherited or acquired retinopathy such as age-related macular degeneration with visual loss

18. Sarcoidosis

19. Diabetes mellitus of any degree even if diet or insulin controlled

20. Best corrected visual acuity (BCVA) of less than 20/40 by ETDRS

21. Refractive error of greater than minus-6 diopters

22. Abnormal electroretinogram (ERG)

23. Unable to dilate pupils

24. History of severe eye trauma that might affect the outcome of the study

25. History of psychosis

26. Participation in other investigational drug studies or use of investigational drugs within prior 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	248.538.00007 Boehringer Ingelheim Investigational Site	Birmingham	Alabama	United States
2	248.538.00008 Boehringer Ingelheim Investigational Site	Little Rock	Arkansas	United States
3	248.538.00021 Boehringer Ingelheim Investigational Site	Fountain Valley	California	United States
4	248.538.00022 Boehringer Ingelheim Investigational Site	Los Angeles	California	United States
5	248.538.00001 Boehringer Ingelheim Investigational Site	New Haven	Connecticut	United States
6	248.538.00002 Boehringer Ingelheim Investigational Site	Miami	Florida	United States
7	248.538.00016 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
8	248.538.00023 Boehringer Ingelheim Investigational Site	Tampa	Florida	United States
9	248.538.00013 Boehringer Ingelheim Investigational Site	Atlanta	Georgia	United States
10	248.538.00009 Boehringer Ingelheim Investigational Site	Augusta	Georgia	United States
11	248.538.00011 Boehringer Ingelheim Investigational Site	Chicago	Illinois	United States
12	248.538.00005 Boehringer Ingelheim Investigational Site	Baltimore	Maryland	United States
13	248.538.00014 Boehringer Ingelheim Investigational Site	Southfield	Michigan	United States
14	248.538.00010 Boehringer Ingelheim Investigational Site	New York	New York	United States
15	248.538.00015 Boehringer Ingelheim Investigational Site	New York	New York	United States
16	248.538.00020 Boehringer Ingelheim Investigational Site	New York	New York	United States
17	248.538.00012 Boehringer Ingelheim Investigational Site	Charlotte	North Carolina	United States
18	248.538.00006 Boehringer Ingelheim Investigational Site	Philadelphia	Pennsylvania	United States
19	248.538.00004 Boehringer Ingelheim Investigational Site	Memphis	Tennessee	United States
20	248.538.00003 Boehringer Ingelheim Investigational Site	Houston	Texas	United States
21	248.538.00017 Boehringer Ingelheim Investigational Site	Morgantown	West Virginia	United States

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT00144300
• Other Study ID Numbers: 248.538
• First Posted: Sep 5, 2005
• Last Update Posted: Mar 14, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Parkinson Disease; Pramipexole

Study Results

Participant Flow

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Period Title: Overall Study
STARTED	121	125
COMPLETED	92	97
NOT COMPLETED	29	28

Baseline Characteristics

Arm/Group Title	Pramipexole	Ropinirole	Total
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated	Total of all reporting groups
Overall Participants	121	125	246
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.5 (9.3)	59.1 (8.7)	58.3 (9.0)
Age, Customized (Number) [Number]
< 50 years	23 19%	17 13.6%	40 16.3%
50 to < 65 years	71 58.7%	74 59.2%	145 58.9%
65 to < 75 years	21 17.4%	30 24%	51 20.7%
>= 75 years	6 5%	4 3.2%	10 4.1%
Sex: Female, Male (Count of Participants)
Female	42 34.7%	47 37.6%	89 36.2%
Male	79 65.3%	78 62.4%	157 63.8%
Race/Ethnicity, Customized (Number) [Number]
Asian	1 0.8%	1 0.8%	2 0.8%
Black	7 5.8%	3 2.4%	10 4.1%
White	113 93.4%	121 96.8%	234 95.1%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	171.3 (9.2)	171.6 (12.4)	171.5 (10.9)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	81.32 (17.64)	82.80 (18.39)	82.07 (18.00)
Duration of Parkinson's disease diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	0.97 (1.15)	1.29 (1.70)	1.13 (1.46)
Hoehn and Yahr stage (Number) [Number]
Stage 0	0 0%	0 0%	0 0%
Stage 1	28 23.1%	23 18.4%	51 20.7%
Stage 1.5	11 9.1%	19 15.2%	30 12.2%
Stage 2	71 58.7%	71 56.8%	142 57.7%
Stage 2.5	8 6.6%	5 4%	13 5.3%
Stage 3	3 2.5%	7 5.6%	10 4.1%
Stage 4	0 0%	0 0%	0 0%
Stage 5	0 0%	0 0%	0 0%
Alcohol history (Number) [Number]
Does not drink	46 38%	49 39.2%	95 38.6%
Has an average consumption	75 62%	76 60.8%	151 61.4%
Fulfills criteria for Abuse/Dependence	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Expert Panel Overall Assessment Following 2 Years on Drug
Description	Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time Frame	up to 2 years

Outcome Measure Data

Analysis Population Description

FAS LOCF - full analysis set with last observation carry forward

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	115	119
Have retinal deterioration	34 28.1%	33 26.4%
Have no retinal deterioration	81 66.9%	86 68.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pramipexole, Ropinirole
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.07
	Confidence Interval	() 95%; 0.71 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Expert Panel Overall Assessment Following 1 Year on Drug
Description	Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time Frame	up to 1 years

Outcome Measure Data

Analysis Population Description

FAS LOCF - full analysis set with last observation carry forward

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	115	119
Have retinal deterioration	28 23.1%	21 16.8%
Have no retinal deterioration	87 71.9%	98 78.4%

3. Secondary Outcome

Title	Hoehn and Yahr Scale at Baseline
Description	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)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Stage 0	0 (0) 0%	0 (0) 0%
Stage 1	28 23.1%	23 18.4%
Stage 1.5	11 9.1%	19 15.2%
Stage 2	71 58.7%	71 56.8%
Stage 2.5	8 6.6%	5 4%
Stage 3	3 2.5%	7 5.6%
Stage 4	0 0%	0 0%
Stage 5	0 0%	0 0%

4. Secondary Outcome

Title	Hoehn and Yahr Scale at 1 Year
Description	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)
Time Frame	Up to 1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Stage 0	1 (1) 0.8%	1 (1) 0.8%
Stage 1	33 27.3%	22 17.6%
Stage 1.5	9 7.4%	16 12.8%
Stage 2	70 57.9%	72 57.6%
Stage 2.5	8 6.6%	8 6.4%
Stage 3	0 0%	6 4.8%
Stage 4	0 0%	0 0%
Stage 5	0 0%	0 0%

5. Secondary Outcome

Title	Hoehn and Yahr Scale at 2 Years
Description	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)
Time Frame	Up to 2 years

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Stage 0	1 (1) 0.8%	0 (0) 0%
Stage 1	27 22.3%	23 18.4%
Stage 1.5	6 5%	12 9.6%
Stage 2	74 61.2%	73 58.4%
Stage 2.5	10 8.3%	10 8%
Stage 3	3 2.5%	7 5.6%
Stage 4	0 0%	0 0%
Stage 5	0 0%	0 0%

6. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
Description	Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	8.0 (3.8)	9.5 (4.7)

7. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
Description	Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	7.0 (4.3)	8.4 (5.0)

8. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
Description	Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame	Baseline, 1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	-1.1 (3.4)	-1.1 (3.6)

9. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
Description	Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	8.4 (4.6)	9.3 (5.2)

10. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
Description	Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
Time Frame	Baseline, 2 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	0.4 (3.7)	-0.2 (4.0)

11. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
Description	Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	20.7 (9.3)	22.4 (10.2)

12. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
Description	Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	17.7 (9.3)	19.8 (10.9)

13. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
Description	Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame	Baseline, 1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	-3.0 (7.2)	-2.6 (6.1)

14. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
Description	Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	19.7 (9.9)	20.9 (10.3)

15. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
Description	Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
Time Frame	Baseline, 2 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	-1.0 (7.9)	-1.5 (7.7)

16. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
Description	This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	28.8 (11.6)	31.9 (13.4)

17. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
Description	This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	24.7 (11.8)	28.2 (14.5)

18. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
Description	This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame	Baseline, 1 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	-4.1 (8.9)	-3.7 (8.2)

19. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
Description	This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	28.1 (12.9)	30.2 (14.1)

20. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
Description	This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
Time Frame	Baseline, 2 year

Outcome Measure Data

Analysis Population Description

TS - treated set

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	121	125
Mean (Standard Deviation) [Score on a scale]	-0.7 (10.1)	-1.7 (10.5)

21. Secondary Outcome

Title	Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
Description	Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.
Time Frame	Screen (Baseline) and final visit (24 months)

Outcome Measure Data

Analysis Population Description

TSlab - treated set with non-missing laboratory evaluations

Arm/Group Title	Pramipexole	Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated	Flexible: 0.25 mg 3 times daily up to maximum tolerated
Measure Participants	109	110
Haematocrit - Decrease	1 0.8%	2 1.6%
Haemoglobin - Decrease	8 6.6%	5 4%
Eosinophils - Increase	4 3.3%	0 0%
Phosphate - Decrease	0 0%	2 1.6%
Calcium - Increase	1 0.8%	0 0%
Glucose - Decrease	4 3.3%	0 0%

Adverse Events

Time Frame	up to 24 months
Arm/Group Title	Pramipexole		Ropinirole
Arm/Group Description	Flexible: 0.125 mg 3 times daily up to maximum tolerated		Flexible: 0.25 mg 3 times daily up to maximum tolerated
All Cause Mortality
	Pramipexole		Ropinirole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pramipexole		Ropinirole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/121 (18.2%)		21/125 (16.8%)
Blood and lymphatic system disorders
Anaemia	0/121 (0%)		1/125 (0.8%)
Haemorrhagic anaemia	1/121 (0.8%)		0/125 (0%)
Cardiac disorders
Acute myocardial infarction	1/121 (0.8%)		0/125 (0%)
Atrial fibrillation	2/121 (1.7%)		1/125 (0.8%)
Bradycardia	0/121 (0%)		1/125 (0.8%)
Cardiac failure congestive	2/121 (1.7%)		0/125 (0%)
Coronary artery occlusion	0/121 (0%)		2/125 (1.6%)
Gastrointestinal disorders
Abdominal pain lower	1/121 (0.8%)		0/125 (0%)
Colitis ischaemic	0/121 (0%)		1/125 (0.8%)
Rectal haemorrhage	0/121 (0%)		1/125 (0.8%)
Small intestinal obstruction	0/121 (0%)		1/125 (0.8%)
General disorders
Chest discomfort	0/121 (0%)		2/125 (1.6%)
Hepatobiliary disorders
Biliary colic	1/121 (0.8%)		0/125 (0%)
Biliary dyskinesia	1/121 (0.8%)		0/125 (0%)
Cholelithiasis	1/121 (0.8%)		0/125 (0%)
Immune system disorders
Hypersensitivity	1/121 (0.8%)		0/125 (0%)
Infections and infestations
Appendicitis	2/121 (1.7%)		0/125 (0%)
Enterocolitis infectious	0/121 (0%)		1/125 (0.8%)
Injury, poisoning and procedural complications
Fall	1/121 (0.8%)		0/125 (0%)
Femur fracture	2/121 (1.7%)		0/125 (0%)
Hand fracture	0/121 (0%)		1/125 (0.8%)
Hip fracture	0/121 (0%)		1/125 (0.8%)
Incisional hernia	1/121 (0.8%)		0/125 (0%)
Jaw fracture	0/121 (0%)		1/125 (0.8%)
Lower limb fracture	2/121 (1.7%)		0/125 (0%)
Post procedural haemorrhage	0/121 (0%)		1/125 (0.8%)
Pubis fracture	1/121 (0.8%)		0/125 (0%)
Rib fracture	1/121 (0.8%)		0/125 (0%)
Road traffic accident	1/121 (0.8%)		2/125 (1.6%)
Stab wound	1/121 (0.8%)		0/125 (0%)
Tibia fracture	0/121 (0%)		1/125 (0.8%)
Metabolism and nutrition disorders
Fluid overload	0/121 (0%)		1/125 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/121 (0.8%)		0/125 (0%)
Arthritis	0/121 (0%)		1/125 (0.8%)
Back pain	1/121 (0.8%)		0/125 (0%)
Groin pain	1/121 (0.8%)		0/125 (0%)
Lumbar spinal stenosis	1/121 (0.8%)		0/125 (0%)
Osteoarthritis	2/121 (1.7%)		2/125 (1.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	5/121 (4.1%)		2/125 (1.6%)
Malignant melanoma	0/121 (0%)		1/125 (0.8%)
Malignant melanoma in situ	0/121 (0%)		1/125 (0.8%)
Ovarian granulosa-theca cell tumour	1/121 (0.8%)		0/125 (0%)
Prostate cancer	1/121 (0.8%)		1/125 (0.8%)
Small cell lung cancer stage unspecified	1/121 (0.8%)		0/125 (0%)
Squamous cell carcinoma	0/121 (0%)		2/125 (1.6%)
Squamous cell carcinoma of skin	1/121 (0.8%)		0/125 (0%)
Transitional cell carcinoma	0/121 (0%)		1/125 (0.8%)
Uterine leiomyoma	1/121 (0.8%)		0/125 (0%)
Nervous system disorders
Brain mass	1/121 (0.8%)		0/125 (0%)
Loss of consciousness	0/121 (0%)		1/125 (0.8%)
Syncope	0/121 (0%)		1/125 (0.8%)
Transient global amnesia	0/121 (0%)		1/125 (0.8%)
Psychiatric disorders
Delirium	0/121 (0%)		1/125 (0.8%)
Delusion	0/121 (0%)		1/125 (0.8%)
Hallucination, visual	0/121 (0%)		1/125 (0.8%)
Psychotic disorder	1/121 (0.8%)		0/125 (0%)
Renal and urinary disorders
Urinary incontinence	0/121 (0%)		1/125 (0.8%)
Reproductive system and breast disorders
Cystocele	0/121 (0%)		1/125 (0.8%)
Endometrial hyperplasia	1/121 (0.8%)		0/125 (0%)
Hyperthecosis	1/121 (0.8%)		0/125 (0%)
Prostatomegaly	1/121 (0.8%)		0/125 (0%)
Uterine haemorrhage	0/121 (0%)		1/125 (0.8%)
Uterine polyp	1/121 (0.8%)		0/125 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	1/121 (0.8%)		0/125 (0%)
Vascular disorders
Thrombosis	0/121 (0%)		1/125 (0.8%)
Other (Not Including Serious) Adverse Events
	Pramipexole		Ropinirole
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	97/121 (80.2%)		101/125 (80.8%)
Eye disorders
Vision blurred	7/121 (5.8%)		4/125 (3.2%)
Gastrointestinal disorders
Abdominal pain upper	3/121 (2.5%)		7/125 (5.6%)
Constipation	18/121 (14.9%)		26/125 (20.8%)
Diarrhoea	6/121 (5%)		9/125 (7.2%)
Dry mouth	4/121 (3.3%)		7/125 (5.6%)
Dyspepsia	4/121 (3.3%)		7/125 (5.6%)
Dysphagia	1/121 (0.8%)		8/125 (6.4%)
Nausea	31/121 (25.6%)		59/125 (47.2%)
Vomiting	3/121 (2.5%)		12/125 (9.6%)
General disorders
Chest pain	6/121 (5%)		7/125 (5.6%)
Fatigue	27/121 (22.3%)		25/125 (20%)
Oedema peripheral	22/121 (18.2%)		18/125 (14.4%)
Infections and infestations
Nasopharyngitis	17/121 (14%)		16/125 (12.8%)
Sinusitis	5/121 (4.1%)		7/125 (5.6%)
Upper respiratory tract infection	12/121 (9.9%)		13/125 (10.4%)
Urinary tract infection	7/121 (5.8%)		4/125 (3.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	9/121 (7.4%)		12/125 (9.6%)
Back pain	17/121 (14%)		9/125 (7.2%)
Muscle spasms	7/121 (5.8%)		9/125 (7.2%)
Musculoskeletal pain	3/121 (2.5%)		7/125 (5.6%)
Myalgia	2/121 (1.7%)		8/125 (6.4%)
Pain in extremity	12/121 (9.9%)		13/125 (10.4%)
Nervous system disorders
Dizziness	27/121 (22.3%)		35/125 (28%)
Dizziness postural	9/121 (7.4%)		9/125 (7.2%)
Headache	15/121 (12.4%)		27/125 (21.6%)
Hypoaesthesia	5/121 (4.1%)		9/125 (7.2%)
Paraesthesia	0/121 (0%)		10/125 (8%)
Somnolence	53/121 (43.8%)		71/125 (56.8%)
Sudden onset of sleep	11/121 (9.1%)		16/125 (12.8%)
Psychiatric disorders
Abnormal dreams	8/121 (6.6%)		7/125 (5.6%)
Anxiety	10/121 (8.3%)		14/125 (11.2%)
Depression	8/121 (6.6%)		15/125 (12%)
Insomnia	19/121 (15.7%)		27/125 (21.6%)
Sleep disorder	9/121 (7.4%)		10/125 (8%)
Reproductive system and breast disorders
Erectile dysfunction	7/121 (5.8%)		4/125 (3.2%)
Respiratory, thoracic and mediastinal disorders
Cough	8/121 (6.6%)		7/125 (5.6%)
Skin and subcutaneous tissue disorders
Rash	6/121 (5%)		10/125 (8%)
Vascular disorders
Hypertension	9/121 (7.4%)		10/125 (8%)
Orthostatic hypotension	10/121 (8.3%)		14/125 (11.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.