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

Boehringer Ingelheim0 sites705 target enrollmentJune 1998

ConditionsParkinson Disease

InterventionsPramipexole Bromocriptine and other dopamine agonists

DrugsPramipexole Bromocriptine and other dopamine agonists

Overview

Phase: Phase 4
Intervention: Pramipexole
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 705
Primary Endpoint: Incidence of drug related signs of retinal degeneration
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

June 1998

End Date

June 2000

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Pramixpexole

Intervention: Pramipexole

Bromocriptine and other dopamine agonists

Intervention: Bromocriptine and other dopamine agonists

Outcomes

Primary Outcomes

Incidence of drug related signs of retinal degeneration

Time Frame: up to 8 months

based on the evaluation of assessors blind to the treatment allocation

Secondary Outcomes

Findings in kinetic perimetry(within 2 month after neurologic visit)
Percentage of patients with elevated dark adaptation thresholds(within 2 month after neurologic visit)
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale(within less than 2 months before ophthalmologic visit)
Number of patients with adverse events(up to 2 month after neurologic visit)
Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV(within less than 2 months before ophthalmologic visit)
Assessment of visual acuity(within 2 month after neurologic visit)
Number of abnormal findings in clinical examination in miosis and mydriasis(within 2 month after neurologic visit)
Assessment of colour vision(within 2 month after neurologic visit)
Findings in standardised electroretinography (ERG)(within 2 monhts after neurologic visit)
Assessment of ophthalmological history(within 2 month after neurologic visit)
Assessment of intraocular pressure (mmHg)(within 2 month after neurologic visit)