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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Parkinson Disease

Treatments

Drug: Bromocriptine and other dopamine agonists

Drug: Pramipexole

Study type

Interventional

Funder types

Industry

Identifiers

NCT02233023

248.342

Details and patient eligibility

About

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

Enrollment

705 patients

Sex

All

Volunteers

No 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