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

Completed · Phase 4

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00144300

Run by

Boehringer Ingelheim

People needed

246

Starts

2005-01-01

Last updated by the study team

2014-03-14

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 248.538.00007 Boehringer Ingelheim Investigational Site — 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
• 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
• 248.538.00010 Boehringer Ingelheim Investigational Site — New York, New York, 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
• 248.538.00006 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 248.538.00004 Boehringer Ingelheim Investigational Site — Memphis, Tennessee, United States
• 248.538.00003 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
• 248.538.00017 Boehringer Ingelheim Investigational Site — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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