NCT Number: NCT02233023
Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease
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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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Bromocriptine and other dopamine agonists
DrugPrimary outcomes
-
Incidence of drug related signs of retinal degeneration
Time frame: up to 8 months
based on the evaluation of assessors blind to the treatment allocation
Secondary outcomes
-
Assessment of ophthalmological history
Time frame: within 2 month after neurologic visit
-
Assessment of visual acuity
Time frame: within 2 month after neurologic visit
-
Number of abnormal findings in clinical examination in miosis and mydriasis
Time frame: within 2 month after neurologic visit
including ophthalmoscopy
-
Assessment of intraocular pressure (mmHg)
Time frame: within 2 month after neurologic visit
-
Assessment of colour vision
Time frame: within 2 month after neurologic visit
using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
-
Findings in kinetic perimetry
Time frame: within 2 month after neurologic visit
-
Percentage of patients with elevated dark adaptation thresholds
Time frame: within 2 month after neurologic visit
-
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
Time frame: 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
Time frame: within less than 2 months before ophthalmologic visit
-
Number of patients with adverse events
Time frame: up to 2 month after neurologic visit
-
Findings in standardised electroretinography (ERG)
Time frame: within 2 monhts after neurologic visit
performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard
Sponsors and collaborators
Lead sponsor
Boehringer Ingelheim
Industry
Registry information
Official study title
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
Important dates
- Study start
- 1998
- Primary completion
- 2000
- First posted
- Sep 8, 2014
- Registry last updated
- Sep 8, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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