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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Mirapex; Drug: Requip

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expert Panel Overall Assessment Following 2 Years on Drug	Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expert Panel Overall Assessment Following 1 Year on Drug	Expert panel of ophthalmologists assessed retinal deterioration by a review of the components of the comprehensive ophthalmology assessments	up to 1 years
Hoehn and Yahr Scale at 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)	Baseline
Hoehn and Yahr Scale at 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)	Up to 1 year
Hoehn and Yahr Scale at 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)	Up to 2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.	Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.	1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 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.	Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 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.	2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 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.	Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.	Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.	1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 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.	Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 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.	2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 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.	Baseline, 2 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).	Baseline
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).	1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 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).	Baseline, 1 year
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 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).	2 years
Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 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).	Baseline, 2 year
Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs	Clinical relevant abnormalities for clinical laboratory evaluations Biochemistry and Haematology) and Vital Signs. New abnormal findings or worsening of baseline conditions were reported.	Screen (Baseline) and final visit (24 months)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: September 2, 2005
• First Submitted That Met QC Criteria: September 2, 2005
• First Posted (Estimate): September 5, 2005

Study Record Updates

• Last Update Posted (Estimate): March 14, 2014
• Last Update Submitted That Met QC Criteria: February 17, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Dopamine Agonists; Dopamine Agents; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Pramipexole
• Other Study ID Numbers: 248.538