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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

705 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-06-30

Brief Summary

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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

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pramixpexole

Group Type EXPERIMENTAL

Pramipexole

Intervention Type DRUG

Bromocriptine and other dopamine agonists

Group Type ACTIVE_COMPARATOR

Bromocriptine and other dopamine agonists

Intervention Type DRUG

Interventions

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Pramipexole

Intervention Type DRUG

Bromocriptine and other dopamine agonists

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No