Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

Matched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

NCT02233023•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

Study to assess and compare the safety of long term oral treatment for Parkinson's Disease with pramipexole versus bromocriptine or other dopamine agonists, by measuring cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal degeneration, in a matched pair design

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with idiopathic Parkinson's Disease
•Patients treated consecutively with either pramipexole or bromocriptine (or other dopamine agonists except ropinirole) for at least two and a half years (i.e. 30 months). Interruptions of ongoing dopamine agonists treatment for less than one month per year duration are acceptable, however, interruptions within the last 6 months are not acceptable. Patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 month treatment
•Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria

•Patients who have been treated less than two and a half years (i.e. 30 months) with their actual dopamine agonist (regardless of the duration of treatment with a previous dopamine agonist)
•Patient treated with ropinirole
•Patients with any of the following:
•* Patients with a hereditary retinal disease and/or a family history of hereditary retinal disease
•* Patients with a history of drug-induced retinopathies
•* Patients with a history of surgically or laser-treated diabetic retinopathy
•Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases (e.g. progressive, supranuclear palsy, multisystem atrophy)
•Dementia or other disorders that could impair the signing of informed consent
•Patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to the first visit (patients currently participating in ongoing open-label extension trials with pramipexole may be included if they meet the requirement of 30 months treatment duration

Key Dates

Start Date

June 1, 1998

Primary Completion Date

June 1, 2000

Last Updated

September 8, 2014

Enrollment

705

ACTUAL participants

Conditions

Parkinson Disease

Interventions

Pramipexole

DRUG

Bromocriptine and other dopamine agonists

DRUG

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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: September 8, 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 of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease

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.

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Exercise for Cognitive Excellence in Parkinson's Disease

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

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