Parkinson Disease
Conditions
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
Interventions
DRUGPramipexole
DRUGBromocriptine and other dopamine agonists
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of drug related signs of retinal degeneration | up to 8 months | based on the evaluation of assessors blind to the treatment allocation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | within 2 month after neurologic visit | including ophthalmoscopy |
| Assessment of intraocular pressure (mmHg) | within 2 month after neurologic visit | — |
| Assessment of colour vision | within 2 month after neurologic visit | using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates |
| 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) | within 2 monhts after neurologic visit | performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard |
Outcome results
None listed