Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
Parkinson Disease
About this trial
This is an interventional diagnostic trial for Parkinson Disease
Eligibility Criteria
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: 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. Age at least 30 years. 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. 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. 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: Previous history of allergic response or complications with any dopaminergic agonist drug Atypical PD syndromes History of stereotactic brain surgery Positive hepatitis B (surface antigen) or hepatitis C (antibody) Surgery within 180 days of randomization which would negatively impact participation Folstein's Mini Mental State Examination (MMSE) score of 24 or less History of active epilepsy (seizure) in the past 1 year Third degree AV block or sick sinus syndrome Congestive heart failure, Class III or IV Unstable heart disease such as unstable angina, dysrhythmia, or myocardial infarction in prior 6 months Symptomatic orthostatic hypotension Clinically significant liver disease or renal disease Malignant melanoma or history of previously treated malignant melanoma. 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) Albinism/Albinoidism of any degree, type or syndrome History of glaucoma with or without treatment Inherited or acquired retinopathy such as age-related macular degeneration with visual loss Sarcoidosis Diabetes mellitus of any degree even if diet or insulin controlled Best corrected visual acuity (BCVA) of less than 20/40 by ETDRS Refractive error of greater than minus-6 diopters Abnormal electroretinogram (ERG) Unable to dilate pupils History of severe eye trauma that might affect the outcome of the study History of psychosis Participation in other investigational drug studies or use of investigational drugs within prior 30 days
Sites / Locations
- 248.538.00007 Boehringer Ingelheim Investigational Site
- 248.538.00008 Boehringer Ingelheim Investigational Site
- 248.538.00021 Boehringer Ingelheim Investigational Site
- 248.538.00022 Boehringer Ingelheim Investigational Site
- 248.538.00001 Boehringer Ingelheim Investigational Site
- 248.538.00002 Boehringer Ingelheim Investigational Site
- 248.538.00016 Boehringer Ingelheim Investigational Site
- 248.538.00023 Boehringer Ingelheim Investigational Site
- 248.538.00013 Boehringer Ingelheim Investigational Site
- 248.538.00009 Boehringer Ingelheim Investigational Site
- 248.538.00011 Boehringer Ingelheim Investigational Site
- 248.538.00005 Boehringer Ingelheim Investigational Site
- 248.538.00014 Boehringer Ingelheim Investigational Site
- 248.538.00010 Boehringer Ingelheim Investigational Site
- 248.538.00015 Boehringer Ingelheim Investigational Site
- 248.538.00020 Boehringer Ingelheim Investigational Site
- 248.538.00012 Boehringer Ingelheim Investigational Site
- 248.538.00006 Boehringer Ingelheim Investigational Site
- 248.538.00004 Boehringer Ingelheim Investigational Site
- 248.538.00003 Boehringer Ingelheim Investigational Site
- 248.538.00017 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Mirapex
Requip
Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines
Requip tablets three times daily (TID) dosing according to manufacturer's guidelines