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

Study Overview
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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

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Pramipexole
* Drug: Bromocriptine and other dopamine agonists


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pramixpexole<br> | Drug: Pramipexole<br> <br> |
| Active Comparator: Bromocriptine and other dopamine agonists<br> | Drug: Bromocriptine and other dopamine agonists<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of drug related signs of retinal degeneration | based on the evaluation of assessors blind to the treatment allocation | up to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of ophthalmological history |  | within 2 month after neurologic visit | 
| Assessment of visual acuity |  | within 2 month after neurologic visit | 
| Number of abnormal findings in clinical examination in miosis and mydriasis | including ophthalmoscopy | within 2 month after neurologic visit | 
| Assessment of intraocular pressure (mmHg) |  | within 2 month after neurologic visit | 
| Assessment of colour vision | using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates | within 2 month after neurologic visit | 
| 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 | 
| 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 | 
| Number of patients with adverse events |  | up to 2 month after neurologic visit | 
| Findings in standardised electroretinography (ERG) | performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard | within 2 monhts after neurologic visit |