Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

Condition(s) targeted: Parkinson Disease

Intervention: pramipexole IR (Drug); ropinirole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

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.

Official title: A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

Study design: Diagnostic, Parallel Assignment, Safety Study

Primary outcome: To determine if there is any difference in the presence of retinal deterioration in Parkinson's disease patients treated with pramipexole versus ropinirole.

Secondary outcome: To assess and monitor safety and tolerability of pramipexole versus ropinirole in Parkinson's disease patients and to assess progression of Parkinson's disease over the study period.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

23. History of severe eye trauma that might affect the outcome of the study 24. History of psychosis 25. Participation in other investigational drug studies or use of investigational drugs within prior 30 days

Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com

248.538.00007 Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States; Recruiting

248.538.00008 Boehringer Ingelheim Investigational Site, Little Rock, Arkansas, United States; Recruiting

248.538.00021 Boehringer Ingelheim Investigational Site, Fountain Valley, California, United States; Recruiting

248.538.00022 Boehringer Ingelheim Investigational Site, Los Angeles, California, United States; Recruiting

248.538.00001 Boehringer Ingelheim Investigational Site, New Haven, Connecticut, United States; Recruiting

248.538.00002 Boehringer Ingelheim Investigational Site, Miami, Florida, United States; Recruiting

248.538.00016 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States; Recruiting

248.538.00023 Boehringer Ingelheim Investigational Site, Tampa, Florida, United States; Recruiting

248.538.00009 Boehringer Ingelheim Investigational Site, Augusta, Georgia, United States; Recruiting

248.538.00013 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States; Recruiting

248.538.00011 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States; Recruiting

248.538.00005 Boehringer Ingelheim Investigational Site, Baltimore, Maryland, United States; Recruiting

248.538.00014 Boehringer Ingelheim Investigational Site, Southfield, Michigan, United States; Recruiting

248.538.00010 Boehringer Ingelheim Investigational Site, New York, New York, United States; Recruiting

248.538.00015 Boehringer Ingelheim Investigational Site, New York, New York, United States; Recruiting

248.538.00020 Boehringer Ingelheim Investigational Site, New York, New York, United States; Recruiting

248.538.00012 Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States; Recruiting

248.538.00006 Boehringer Ingelheim Investigational Site, Philadelphia, Pennsylvania, United States; Recruiting

248.538.00004 Boehringer Ingelheim Investigational Site, Memphis, Tennessee, United States; Recruiting

248.538.00003 Boehringer Ingelheim Investigational Site, Houston, Texas, United States; Recruiting

248.538.00017 Boehringer Ingelheim Investigational Site, Morgantown, West Virginia, United States; Recruiting

Starting date: January 2005
Last updated: October 20, 2008