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.

Condition	Intervention	Phase
Parkinson Disease	Drug: pramipexole	Phase IV

Further Study Details: 

Primary Outcomes: To determine if there is any difference in the presence of retinal deterioration in Parkinson''''s disease patients treated with pramipexole versus ropinirole.
Secondary Outcomes: To assess and monitor safety and tolerability of pramipexole versus ropinirole in Parkinson''''s disease patients; to assess progression of Parkinson''''s disease over the study period.
Expected Total Enrollment:  300

Ages Eligible for Study:  30 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Diagnosis and main criteria for inclusion: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study (all time periods are calculated from randomization.):

1. Patients with idiopathic Parkinson''''s disease for at least 2 years confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity; and characterized as Stage I-III by the Modified Hoehn and Yahr Scale.
2. On stable dosage of levodopa for at least 4 weeks.
3. Age between 30 and 80 years old
4. 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.
5. 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.
6. Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
7. HAMD total score of greater than 15.
8. Mini-Mental State Examination (MMSE) score greater than 23.

Please refer to this study by ClinicalTrials.gov identifier  NCT00144300

Leona Borchert, Dr.      +1 (203) 798-4901  Ext. 4901    lborcher@rdg.boehringer-ingelheim.com

Alabama
      619 19th Street, South, Birmingham,  Alabama,  United States; Recruiting
Arkansas
      501 Steohens Dr., Little Rock,  Arkansas,  United States; Recruiting
California
      Attn: Daniel Truong, M.D., Fountain Valley,  California,  United States; Recruiting
      USC / Keck school of Medicine, Los Angeles,  California,  United States; Recruiting
Connecticut
      60 Temple St, New Haven,  Connecticut,  United States; Recruiting
Florida
      12901 Bruce B. Downs Blvd., Tampa,  Florida,  United States; Recruiting
      1501 N.W. 9th Ave, Miami,  Florida,  United States; Not yet recruiting
Georgia
      1429 Harper St., Augusta,  Georgia,  United States; Recruiting
      1841 Clifton Rd., Atlanta,  Georgia,  United States; Recruiting
Michigan
      26400 W. 12 Mile Road, Southfield,  Michigan,  United States; Recruiting
New York
      Mount Sinai Medical Center, New York,  New York,  United States; Not yet recruiting
      Mount Sinai Medical Center, New York,  New York,  United States; Recruiting
      710 W. 168th Street, New York,  New York,  United States; Not yet recruiting
      10 Union Square, New York,  New York,  United States; Not yet recruiting
North Carolina
      1700 Abbey Place, Charlotte,  North Carolina,  United States; Recruiting
      932 Morreene Road #264, Durham,  North Carolina,  United States; Not yet recruiting
      Chapel Hill,  North Carolina,  United States; Not yet recruiting
Pennsylvania
      330 S. 9th Street, Philadelphia,  Pennsylvania,  United States; Recruiting
Tennessee
      855 Monroe Ave, Memphis,  Tennessee,  United States; Recruiting
Texas
      Smith Tower, Houston,  Texas,  United States; Recruiting
West Virginia
      1 Stadium Drive, Morgantown,  West Virginia,  United States; Recruiting

Study chairs or principal investigators

Leona Borchert, Dr.,  Study Chair,  Boehringer Ingelheim Pharmaceuticals   

Study ID Numbers:  248.538
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144300
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06