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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00144300
First received: September 2, 2005
Last updated: February 17, 2014
Last verified: February 2014
  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: Mirapex
Drug: Requip
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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:

Primary Outcome Measures:
  • Expert Panel Overall Assessment Following 2 Years on Drug [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments


Secondary Outcome Measures:
  • Expert Panel Overall Assessment Following 1 Year on Drug [ Time Frame: up to 1 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.


Enrollment: 246
Study Start Date: January 2005
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mirapex
Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines
Drug: Mirapex
Standard marketed product dispensed according to manufacturer's guidelines
Active Comparator: Requip
Requip tablets three times daily (TID) dosing according to manufacturer's guidelines
Drug: Requip
Standard marketed product dispensed according to manufacturer's guidelines

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 21 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00144300     History of Changes
Other Study ID Numbers: 248.538
Study First Received: September 2, 2005
Results First Received: September 16, 2011
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014