Parkinson Disease
Conditions
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.
Interventions
DRUGMirapex
Standard marketed product dispensed according to manufacturer's guidelines
DRUGRequip
Standard marketed product dispensed according to manufacturer's guidelines
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pramipexole Flexible: 0.125 mg 3 times daily up to maximum tolerated | 121 |
| Ropinirole Flexible: 0.25 mg 3 times daily up to maximum tolerated | 125 |
| Total | 246 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 16 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Other reason (not specified) | 1 | 3 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Total | Pramipexole | Ropinirole |
|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 9 | 57.5 years STANDARD_DEVIATION 9.3 | 59.1 years STANDARD_DEVIATION 8.7 |
| Age, Customized 50 to < 65 years | 145 Participants | 71 Participants | 74 Participants |
| Age, Customized < 50 years | 40 Participants | 23 Participants | 17 Participants |
| Age, Customized 65 to < 75 years | 51 Participants | 21 Participants | 30 Participants |
| Age, Customized >= 75 years | 10 Participants | 6 Participants | 4 Participants |
| Alcohol history Does not drink | 95 Participants | 46 Participants | 49 Participants |
| Alcohol history Fulfills criteria for Abuse/Dependence | 0 Participants | 0 Participants | 0 Participants |
| Alcohol history Has an average consumption | 151 Participants | 75 Participants | 76 Participants |
| Duration of Parkinson's disease diagnosis | 1.13 years STANDARD_DEVIATION 1.46 | 0.97 years STANDARD_DEVIATION 1.15 | 1.29 years STANDARD_DEVIATION 1.7 |
| Height | 171.5 centimeters STANDARD_DEVIATION 10.9 | 171.3 centimeters STANDARD_DEVIATION 9.2 | 171.6 centimeters STANDARD_DEVIATION 12.4 |
| Hoehn and Yahr stage Stage 0 | 0 Participants | 0 Participants | 0 Participants |
| Hoehn and Yahr stage Stage 1 | 51 Participants | 28 Participants | 23 Participants |
| Hoehn and Yahr stage Stage 1.5 | 30 Participants | 11 Participants | 19 Participants |
| Hoehn and Yahr stage Stage 2 | 142 Participants | 71 Participants | 71 Participants |
| Hoehn and Yahr stage Stage 2.5 | 13 Participants | 8 Participants | 5 Participants |
| Hoehn and Yahr stage Stage 3 | 10 Participants | 3 Participants | 7 Participants |
| Hoehn and Yahr stage Stage 4 | 0 Participants | 0 Participants | 0 Participants |
| Hoehn and Yahr stage Stage 5 | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 234 Participants | 113 Participants | 121 Participants |
| Sex: Female, Male Female | 89 Participants | 42 Participants | 47 Participants |
| Sex: Female, Male Male | 157 Participants | 79 Participants | 78 Participants |
| Weight | 82.07 kilograms STANDARD_DEVIATION 18 | 81.32 kilograms STANDARD_DEVIATION 17.64 | 82.80 kilograms STANDARD_DEVIATION 18.39 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 97 / 121 | 101 / 125 |
| serious Total, serious adverse events | 22 / 121 | 21 / 125 |
Outcome results
Primary
Expert Panel Overall Assessment Following 2 Years on Drug
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time frame: up to 2 years
Population: FAS LOCF - full analysis set with last observation carry forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Expert Panel Overall Assessment Following 2 Years on Drug | Have retinal deterioration | 34 Participants |
| Pramipexole | Expert Panel Overall Assessment Following 2 Years on Drug | Have no retinal deterioration | 81 Participants |
| Ropinirole | Expert Panel Overall Assessment Following 2 Years on Drug | Have retinal deterioration | 33 Participants |
| Ropinirole | Expert Panel Overall Assessment Following 2 Years on Drug | Have no retinal deterioration | 86 Participants |
95% CI: [0.71, 1.6]
Secondary
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
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)
Population: TSlab - treated set with non-missing laboratory evaluations
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Haematocrit - Decrease | 1 participants |
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Haemoglobin - Decrease | 8 participants |
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Eosinophils - Increase | 4 participants |
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Phosphate - Decrease | 0 participants |
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Calcium - Increase | 1 participants |
| Pramipexole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Glucose - Decrease | 4 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Calcium - Increase | 0 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Haematocrit - Decrease | 2 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Phosphate - Decrease | 2 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Haemoglobin - Decrease | 5 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Glucose - Decrease | 0 participants |
| Ropinirole | Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Eosinophils - Increase | 0 participants |
Secondary
Expert Panel Overall Assessment Following 1 Year on Drug
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
Time frame: up to 1 years
Population: FAS LOCF - full analysis set with last observation carry forward
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Expert Panel Overall Assessment Following 1 Year on Drug | Have retinal deterioration | 28 Participants |
| Pramipexole | Expert Panel Overall Assessment Following 1 Year on Drug | Have no retinal deterioration | 87 Participants |
| Ropinirole | Expert Panel Overall Assessment Following 1 Year on Drug | Have retinal deterioration | 21 Participants |
| Ropinirole | Expert Panel Overall Assessment Following 1 Year on Drug | Have no retinal deterioration | 98 Participants |
Secondary
Hoehn and Yahr Scale at 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)
Time frame: Up to 1 year
Population: TS - treated set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 0 | 1 Participants | 1 |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 1 | 33 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 1.5 | 9 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 2 | 70 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 2.5 | 8 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 3 | 0 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 4 | 0 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 1 Year | Stage 5 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 5 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 0 | 1 Participants | 1 |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 2.5 | 8 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 1 | 22 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 4 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 1.5 | 16 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 3 | 6 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 1 Year | Stage 2 | 72 Participants | — |
Secondary
Hoehn and Yahr Scale at 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)
Time frame: Up to 2 years
Population: TS - treated set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 1.5 | 6 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 3 | 3 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 1 | 27 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 4 | 0 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 2 | 74 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 5 | 0 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 2.5 | 10 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at 2 Years | Stage 0 | 1 Participants | 1 |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 2 | 73 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 0 | 0 Participants | 0 |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 1 | 23 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 1.5 | 12 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 2.5 | 10 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 3 | 7 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 4 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at 2 Years | Stage 5 | 0 Participants | — |
Secondary
Hoehn and Yahr Scale at 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)
Time frame: Baseline
Population: TS - treated set
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 5 | 0 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 2 | 71 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 1 | 28 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 2.5 | 8 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 0 | 0 Participants | 0 |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 3 | 3 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 1.5 | 11 Participants | — |
| Pramipexole | Hoehn and Yahr Scale at Baseline | Stage 4 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 1.5 | 19 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 5 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 0 | 0 Participants | 0 |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 1 | 23 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 4 | 0 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 2 | 71 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 2.5 | 5 Participants | — |
| Ropinirole | Hoehn and Yahr Scale at Baseline | Stage 3 | 7 Participants | — |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 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.
Time frame: Baseline, 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year | -1.1 Score on a scale | Standard Deviation 3.4 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year | -1.1 Score on a scale | Standard Deviation 3.6 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 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.
Time frame: Baseline, 2 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years | 0.4 Score on a scale | Standard Deviation 3.7 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years | -0.2 Score on a scale | Standard Deviation 4 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 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.
Time frame: Baseline, 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year | -3.0 Score on a scale | Standard Deviation 7.2 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year | -2.6 Score on a scale | Standard Deviation 6.1 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 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.
Time frame: Baseline, 2 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years | -1.0 Score on a scale | Standard Deviation 7.9 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years | -1.5 Score on a scale | Standard Deviation 7.7 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.
Time frame: 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year | 17.7 Score on a scale | Standard Deviation 9.3 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year | 19.8 Score on a scale | Standard Deviation 10.9 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.
Time frame: 2 years
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years | 19.7 Score on a scale | Standard Deviation 9.9 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years | 20.9 Score on a scale | Standard Deviation 10.3 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.
Time frame: Baseline
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline | 20.7 Score on a scale | Standard Deviation 9.3 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline | 22.4 Score on a scale | Standard Deviation 10.2 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.
Time frame: 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year | 7.0 Score on a scale | Standard Deviation 4.3 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year | 8.4 Score on a scale | Standard Deviation 5 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.
Time frame: 2 years
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years | 8.4 Score on a scale | Standard Deviation 4.6 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years | 9.3 Score on a scale | Standard Deviation 5.2 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.
Time frame: Baseline
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline | 8.0 Score on a scale | Standard Deviation 3.8 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline | 9.5 Score on a scale | Standard Deviation 4.7 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 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).
Time frame: Baseline, 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year | -4.1 Score on a scale | Standard Deviation 8.9 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year | -3.7 Score on a scale | Standard Deviation 8.2 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 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).
Time frame: Baseline, 2 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years | -0.7 Score on a scale | Standard Deviation 10.1 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years | -1.7 Score on a scale | Standard Deviation 10.5 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).
Time frame: 1 year
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year | 24.7 Score on a scale | Standard Deviation 11.8 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year | 28.2 Score on a scale | Standard Deviation 14.5 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).
Time frame: 2 years
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years | 28.1 Score on a scale | Standard Deviation 12.9 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years | 30.2 Score on a scale | Standard Deviation 14.1 |
Secondary
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).
Time frame: Baseline
Population: TS - treated set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline | 28.8 Score on a scale | Standard Deviation 11.6 |
| Ropinirole | Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline | 31.9 Score on a scale | Standard Deviation 13.4 |