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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pramixpexole | Experimental |
| |
| Bromocriptine and other dopamine agonists | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug |
| ||
| Bromocriptine and other dopamine agonists |
| 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 |
| 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 |
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Inclusion Criteria:
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 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
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|
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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| D001971 | Bromocriptine |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004879 | Ergotamines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D004873 | Ergolines |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
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