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Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00144300
First Posted: September 5, 2005
Last Update Posted: March 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
September 2, 2005
September 5, 2005
September 16, 2011
November 4, 2011
March 14, 2014
January 2005
September 2010   (Final data collection date for primary outcome measure)
Expert Panel Overall Assessment Following 2 Years on Drug [ Time Frame: up to 2 years ]
Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
To determine if there is any difference in the presence of retinal deterioration in Parkinson's disease patients treated with pramipexole versus ropinirole.
Complete list of historical versions of study NCT00144300 on ClinicalTrials.gov Archive Site
  • Expert Panel Overall Assessment Following 1 Year on Drug [ Time Frame: up to 1 years ]
    Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments
  • Hoehn and Yahr Scale at Baseline [ Time Frame: Baseline ]
    This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
  • Hoehn and Yahr Scale at 1 Year [ Time Frame: Up to 1 year ]
    This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
  • Hoehn and Yahr Scale at 2 Years [ Time Frame: Up to 2 years ]
    This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden)
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline [ Time Frame: Baseline ]
    Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year [ Time Frame: 1 year ]
    Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year [ Time Frame: Baseline, 1 year ]
    Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years [ Time Frame: 2 years ]
    Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years [ Time Frame: Baseline, 2 year ]
    Part II of the UPDRS collected retrospective information on patient functioning in various activities of daily living. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 52.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline [ Time Frame: Baseline ]
    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year [ Time Frame: 1 year ]
    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year [ Time Frame: Baseline, 1 year ]
    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years [ Time Frame: 2 years ]
    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years [ Time Frame: Baseline, 2 year ]
    Part III of the UPDRS contained the clinician-scored motor evaluation. Individual items scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56.
  • Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline [ Time Frame: Baseline ]
    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
  • Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year [ Time Frame: 1 year ]
    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
  • Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year [ Time Frame: Baseline, 1 year ]
    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
  • Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years [ Time Frame: 2 years ]
    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
  • Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years [ Time Frame: Baseline, 2 year ]
    This is the sum of Part II and Part III of the UPDRS. The total score ranged from 0 (Normal) to 108 (Extreme dysfunction).
  • Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs [ Time Frame: Screen (Baseline) and final visit (24 months) ]
    Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.
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.
Not Provided
Not Provided
 
Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Parkinson Disease
  • Drug: Mirapex
    Standard marketed product dispensed according to manufacturer's guidelines
  • Drug: Requip
    Standard marketed product dispensed according to manufacturer's guidelines
  • Active Comparator: Mirapex
    Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines
    Intervention: Drug: Mirapex
  • Active Comparator: Requip
    Requip tablets three times daily (TID) dosing according to manufacturer's guidelines
    Intervention: Drug: Requip
Seiple W, Jennings D, Rosen RB, Borchert L, Canale L, Fagan N, Gordon MF. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease. Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
Not Provided
September 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
  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
Sexes Eligible for Study: All
30 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00144300
248.538
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP