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Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
This study is ongoing, but not recruiting participants.
Study NCT00144300.   Last updated on January 27, 2009.
Information provided by Boehringer Ingelheim Pharmaceuticals
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Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients
A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients

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.

Phase IV
Interventional
Diagnostic, Parallel Assignment, Safety Study
To determine if there is any difference in the presence of retinal deterioration in Parkinson's disease patients treated with pramipexole versus ropinirole. [ Time Frame: 24 months ]
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. [ Time Frame: 24 months ]
Parkinson Disease
Drug: pramipexole IR
Drug: ropinirole
 
Active, not recruiting
300
January 2005
July 2010   (final data collection date for primary outcome measure)

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

Both
30 Years and older
No
United States
 
NCT00144300
248.538
Boehringer Ingelheim Pharmaceuticals
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
January 2009
September 2, 2005
January 27, 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.