NCT02233023已完成4 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 705
- 主要终点
- Incidence of drug related signs of retinal degeneration
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pramixpexole
Experimental
干预措施: Pramipexole (Drug)
Bromocriptine and other dopamine agonists
Active Comparator
干预措施: Bromocriptine and other dopamine agonists (Drug)
结局指标
主要结局
Incidence of drug related signs of retinal degeneration
时间窗: up to 8 months
based on the evaluation of assessors blind to the treatment allocation
次要结局
- 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)
- Number of patients with adverse events(up to 2 month after neurologic 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)
- 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)
- Assessment of colour vision(within 2 month after neurologic visit)
- Findings in standardised electroretinography (ERG)(within 2 monhts after neurologic visit)
- Assessment of ophthalmological history(within 2 month after neurologic visit)
- Assessment of intraocular pressure (mmHg)(within 2 month after neurologic visit)
研究者
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