Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Mirapex; Requip
Intervention description: Standard marketed product dispensed according to manufacturer's guidelines; Standard marketed product dispensed according to manufacturer's guidelines
Intervention MeSH terms: Pramipexole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 246.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

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.
    

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:

          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