EUCTR2005-001006-12-DE进行中（未招募）1 期
Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO
Axxonis Pharma GmbH0 个研究点目标入组 60 人开始时间: 2006年9月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or Female patients
- •Age 18 - 75 years
- •Idiopathic Parkinson’s disease for at least 3 years (diagnosis based on the UK Brain Bank Criteria)
- •Presence of motor fluctuations (wearing-off or other OFF periods) and / or presence of troublesome dyskinesia, with a total daily minimum of at least 4 hours, despite optimized oral anti-parkinsonian therapy
- •Stable levodopa intake, i.e. at least four doses of levodopa per day
- •Stable dosing of all other anti-parkinsonian drugs, such as dopamine agonists, COMT- and MAO-B inhibitors, amantadine, or anticholin-ergics for a minimum of four weeks prior to inclusion.
- •The following oral dopamine agonist drugs are allowed in this trial: pramipexol up to a total daily dose of 3,15mg, ropinirol up to a total daily dose of 24mg, cabergoline up to a total daily dose of 6mg or combinations
- •Concomitant diseases are stable and well controlled
- •Willingness and ability to comply with all trial requirements
- •Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non-idiopathic Parkinson’s disease (e.g. drug-induced or other forms of secondary or atypical parkinsonism such as MSA)
- •Significant neurological symptoms not accounted for by Parkinson’s disease
- •History or presence of dementia according to clinical impressions
- •Mini-mental status examination (MMSE < 24)
- •Presence of major depression according to DSM IV criteria (= 6 months)
- •History or presence of epilepsy
- •Presence of dopaminergic psychosis
- •Unstable severe concomitant diseases (e.g. liver diseases, kidney diseases or clinically relevant cardiac or coronary dysfunction)
- •Presence of heart valvular fibrosis or indication of significant valvular stenosis / insufficiency on echocardiogram
- •History of syncope and/or severe or otherwise symptomatic orthostatic hypotension
- •Present treatment with neuroleptics, including atypical neuroleptics
- •Treatment with other CNS active drug therapy (e.g. sedatives, hypnotics, anti-depressants, anxiolytics) unless the dose has been stable for at least four weeks prior to the baseline visit
- •Participation in another trial of an investigational drug within the last 28 days or current participation in another trial of an investigational drug
- •Clinically significant laboratory abnormalities
- •Previous neurosurgery for Parkinson’s disease
- •Alcohol or drug abuse in the past three years
- •Women of childbearing potential without adequate and effective form of birth control with a Pearl index <1% (e.g. abstinence, hormonal contraception, hormonal IUD)
- •Pregnancy or lactation
- •Known hypersensitivity to Lisurid, Ropinirole, Pramipexol, Cabergoline, or other ergoline substances.
- •History of pleural effusion or fibrosis or acute pulmonary fibrosis.
- •Raynaud-syndrome
- •Known gastro-intestinal ulcers or bleedings
- •Clinically significant liver failure (total bilirubin > 2.0 mg/dl or SGOT and/or SGPT greater than two times the upper limit of the reference range)
- •Clinically relevant renal dysfunction (serum creatinine > 2.0 mg/dl)
- •QTc interval > 470 msec at screening ECG
- •Co-medication with drugs prolonging the QTc interval
- •Other known risk factors for Torsades de Pointes arrhythmias (e.g. cardiac insufficiency NYHA II-IV, hypokalemia, hereditary long-QT-syndrome)
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