Status:
COMPLETED
Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Parkinson Disease
Eligibility:
All Genders
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 Trial Info
Start Date :
June 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
705 Patients enrolled
Trial Details
Trial ID
NCT02233023
Start Date
June 1 1998
Last Update
September 8 2014
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