Clinical trial NCT00144300: Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 246
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Expert Panel Overall Assessment Following 2 Years on Drug
timeFrame: up to 2 years
Secondary outcomes:
measure: Expert Panel Overall Assessment Following 1 Year on Drug
timeFrame: up to 1 years
measure: Hoehn and Yahr Scale at Baseline
timeFrame: Baseline
measure: Hoehn and Yahr Scale at 1 Year
timeFrame: Up to 1 year
measure: Hoehn and Yahr Scale at 2 Years
timeFrame: Up to 2 years
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at Baseline
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 1 Year
timeFrame: 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 1 Year
timeFrame: Baseline, 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Total Score at 2 Years
timeFrame: 2 years
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part II, Change From Baseline in Total Score at 2 Years
timeFrame: Baseline, 2 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at Baseline
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 1 Year
timeFrame: 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 1 Year
timeFrame: Baseline, 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Total Score at 2 Years
timeFrame: 2 years
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Part III, Change From Baseline in Total Score at 2 Years
timeFrame: Baseline, 2 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at Baseline
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 1 Year
timeFrame: 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 1 Year
timeFrame: Baseline, 1 year
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Total Score at 2 Years
timeFrame: 2 years
measure: Unified Parkinson's Disease Rating Scale (UPDRS), Parts II and III, Change From Baseline in Total Score at 2 Years
timeFrame: Baseline, 2 year
measure: Clinical Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs
timeFrame: Screen (Baseline) and final visit (24 months)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 248.538.00007 Boehringer Ingelheim Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: 248.538.00008 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Fountain Valley
country: United States
facility: 248.538.00021 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 248.538.00022 Boehringer Ingelheim Investigational Site
state: California
city: New Haven
country: United States
facility: 248.538.00001 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Miami
country: United States
facility: 248.538.00002 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.538.00016 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 248.538.00023 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 248.538.00013 Boehringer Ingelheim Investigational Site
state: Georgia
city: Augusta
country: United States
facility: 248.538.00009 Boehringer Ingelheim Investigational Site
state: Georgia
city: Chicago
country: United States
facility: 248.538.00011 Boehringer Ingelheim Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: 248.538.00005 Boehringer Ingelheim Investigational Site
state: Maryland
city: Southfield
country: United States
facility: 248.538.00014 Boehringer Ingelheim Investigational Site
state: Michigan
city: New York
country: United States
facility: 248.538.00010 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.538.00015 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 248.538.00020 Boehringer Ingelheim Investigational Site
state: New York
city: Charlotte
country: United States
facility: 248.538.00012 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: 248.538.00006 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: 248.538.00004 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Houston
country: United States
facility: 248.538.00003 Boehringer Ingelheim Investigational Site
state: Texas
city: Morgantown
country: United States
facility: 248.538.00017 Boehringer Ingelheim Investigational Site
state: West Virginia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.