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

Boehringer Ingelheim246 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

246

Conditions

Parkinson Disease

Interventions

MirapexDRUG

Standard marketed product dispensed according to manufacturer's guidelines

RequipDRUG

Standard marketed product dispensed according to manufacturer's guidelines

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (21)

248.538.00007 Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

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

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

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

248.538.00008 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

248.538.00021 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

248.538.00022 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

248.538.00001 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

248.538.00002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

248.538.00016 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

248.538.00023 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

248.538.00013 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

248.538.00009 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

...and 11 more locations

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year

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

Time frame: Baseline, 1 year

Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years

Time frame: 2 years

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

Time frame: Baseline, 2 year

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