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

This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, October 2008

Sponsored by: 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

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

Drug Information available for:   Pramipexol    Pramipexole dihydrochloride    Ropinirole    Ropinirole hydrochloride   

U.S. FDA Resources

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

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:   July 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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00144300

Contacts
Contact: Boehringer Ingelheim Study Coordinator     clintriage.rdg@boehringer-ingelheim.com    

Show 21 study locations  Show 21 Study Locations

Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals

Investigators
Study Chair:     Boehringer Ingelheim     Boehringer Ingelheim Pharmaceuticals    
  More Information


Responsible Party:   Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:   248.538
First Received:   September 2, 2005
Last Updated:   October 20, 2008
ClinicalTrials.gov Identifier:   NCT00144300
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Ropinirole
Dopamine
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Pramipexol

Additional relevant MeSH terms:
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agonists
Protective Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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