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

NCT ID: NCT00144300

Last Updated: 2014-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mirapex

Mirapex tablets three times daily (TID) dosing according to manufacturer's guidelines

Group Type ACTIVE_COMPARATOR

Mirapex

Intervention Type DRUG

Standard marketed product dispensed according to manufacturer's guidelines

Requip

Requip tablets three times daily (TID) dosing according to manufacturer's guidelines

Group Type ACTIVE_COMPARATOR

Requip

Intervention Type DRUG

Standard marketed product dispensed according to manufacturer's guidelines

Interventions

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Mirapex

Standard marketed product dispensed according to manufacturer's guidelines

Intervention Type DRUG

Requip

Standard marketed product dispensed according to manufacturer's guidelines

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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248.538.00007 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

248.538.00008 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

Site Status

248.538.00021 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Site Status

248.538.00022 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

248.538.00001 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

Site Status

248.538.00002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

Site Status

248.538.00016 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

248.538.00023 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

248.538.00013 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Site Status

248.538.00009 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Site Status

248.538.00011 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

Site Status

248.538.00005 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Site Status

248.538.00014 Boehringer Ingelheim Investigational Site

Southfield, Michigan, United States

Site Status

248.538.00010 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

248.538.00015 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

248.538.00020 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

248.538.00012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Site Status

248.538.00006 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

248.538.00004 Boehringer Ingelheim Investigational Site

Memphis, Tennessee, United States

Site Status

248.538.00003 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

248.538.00017 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28078162 (View on PubMed)

Other Identifiers

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248.538

Identifier Type: -

Identifier Source: org_study_id

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