Clinical trial NCT02233023: Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 705
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of drug related signs of retinal degeneration
timeFrame: up to 8 months
Secondary outcomes:
measure: Assessment of ophthalmological history
timeFrame: within 2 month after neurologic visit
measure: Assessment of visual acuity
timeFrame: within 2 month after neurologic visit
measure: Number of abnormal findings in clinical examination in miosis and mydriasis
timeFrame: within 2 month after neurologic visit
measure: Assessment of intraocular pressure (mmHg)
timeFrame: within 2 month after neurologic visit
measure: Assessment of colour vision
timeFrame: within 2 month after neurologic visit
measure: Findings in kinetic perimetry
timeFrame: within 2 month after neurologic visit
measure: Percentage of patients with elevated dark adaptation thresholds
timeFrame: within 2 month after neurologic visit
measure: Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
timeFrame: within less than 2 months before ophthalmologic visit
measure: Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV
timeFrame: within less than 2 months before ophthalmologic visit
measure: Number of patients with adverse events
timeFrame: up to 2 month after neurologic visit
measure: Findings in standardised electroretinography (ERG)
timeFrame: within 2 monhts after neurologic visit
Other outcomes:
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