Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
- Registration Number
- NCT00144300
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mirapex Mirapex Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines Requip Requip Requip tablets three times daily (TID) dosing according to manufacturer's guidelines
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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.
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
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 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.
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)
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.
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, 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), 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 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), 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).
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.
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, 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), 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).
Trial Locations
- Locations (21)
248.538.00010 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
248.538.00013 Boehringer Ingelheim Investigational Site
🇺🇸Atlanta, Georgia, United States
248.538.00006 Boehringer Ingelheim Investigational Site
🇺🇸Philadelphia, Pennsylvania, United States
248.538.00022 Boehringer Ingelheim Investigational Site
🇺🇸Los Angeles, California, United States
248.538.00009 Boehringer Ingelheim Investigational Site
🇺🇸Augusta, Georgia, United States
248.538.00021 Boehringer Ingelheim Investigational Site
🇺🇸Fountain Valley, California, United States
248.538.00011 Boehringer Ingelheim Investigational Site
🇺🇸Chicago, Illinois, United States
248.538.00005 Boehringer Ingelheim Investigational Site
🇺🇸Baltimore, Maryland, United States
248.538.00014 Boehringer Ingelheim Investigational Site
🇺🇸Southfield, Michigan, United States
248.538.00015 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
248.538.00020 Boehringer Ingelheim Investigational Site
🇺🇸New York, New York, United States
248.538.00012 Boehringer Ingelheim Investigational Site
🇺🇸Charlotte, North Carolina, United States
248.538.00003 Boehringer Ingelheim Investigational Site
🇺🇸Houston, Texas, United States
248.538.00002 Boehringer Ingelheim Investigational Site
🇺🇸Miami, Florida, United States
248.538.00008 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
248.538.00004 Boehringer Ingelheim Investigational Site
🇺🇸Memphis, Tennessee, United States
248.538.00017 Boehringer Ingelheim Investigational Site
🇺🇸Morgantown, West Virginia, United States
248.538.00007 Boehringer Ingelheim Investigational Site
🇺🇸Birmingham, Alabama, United States
248.538.00001 Boehringer Ingelheim Investigational Site
🇺🇸New Haven, Connecticut, United States
248.538.00016 Boehringer Ingelheim Investigational Site
🇺🇸Tampa, Florida, United States
248.538.00023 Boehringer Ingelheim Investigational Site
🇺🇸Tampa, Florida, United States