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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.
First Received: September 2, 2005   Last Updated: November 23, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00144300
  Purpose

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 IR
Drug: ropinirole
Phase IV

Study Type: Interventional
Study Design: Diagnostic, Parallel Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: January 2005
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144300

  Hide Study Locations
Locations
United States, Alabama
248.538.00007 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arkansas
248.538.00008 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
United States, California
248.538.00021 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
248.538.00022 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
United States, Connecticut
248.538.00001 Boehringer Ingelheim Investigational Site
New Haven, Connecticut, United States
United States, Florida
248.538.00016 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
248.538.00002 Boehringer Ingelheim Investigational Site
Miami, Florida, United States
248.538.00023 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
United States, Georgia
248.538.00009 Boehringer Ingelheim Investigational Site
Augusta, Georgia, United States
248.538.00013 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
United States, Illinois
248.538.00011 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
United States, Maryland
248.538.00005 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Michigan
248.538.00014 Boehringer Ingelheim Investigational Site
Southfield, Michigan, United States
United States, New York
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
United States, North Carolina
248.538.00012 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
United States, Pennsylvania
248.538.00006 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
248.538.00004 Boehringer Ingelheim Investigational Site
Memphis, Tennessee, United States
United States, Texas
248.538.00003 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
United States, West Virginia
248.538.00017 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia, United States
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 248.538
Study First Received: September 2, 2005
Last Updated: November 23, 2009
ClinicalTrials.gov Identifier: NCT00144300     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neurotransmitter Agents
Ropinirole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Protective Agents
Pramipexol
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009