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

COMPLETEDPHASE4

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

NCT00144300•Boehringer Ingelheim

View on ClinicalTrials.gov

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

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

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
+17 more criteria

Locations (21)

248.538.00007 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

248.538.00008 Boehringer Ingelheim Investigational Site

Little Rock, Arkansas, United States

248.538.00021 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

248.538.00022 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

248.538.00001 Boehringer Ingelheim Investigational Site

New Haven, Connecticut, United States

248.538.00002 Boehringer Ingelheim Investigational Site

Miami, Florida, United States

248.538.00016 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

248.538.00023 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

248.538.00013 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

248.538.00009 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Key Dates

Start Date

January 1, 2005

Primary Completion Date

September 1, 2010

Last Updated

March 14, 2014

Enrollment

246

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Mirapex

DRUG

Requip

DRUG

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

View study

RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 14, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations