EUCTR2008-006270-15-DE进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy and tolerability of AFQ056 in reducing L-dopa induced dyskinesias in Parkinson’s patients with severe motor complications
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Patients who are eligible for enrollment in the study will be males and females, aged between 30 and 85 years of age (both inclusive), non-smokers, with idiopathic Parkinson’s disease (diagnosed by UK Parkinson’s disease Society Brain Bank criteria), with an AIMS score of 18 or greater, with L-dopa induced dyskinesia greater than 20% (UPDRS item of 32, rating =1) of moderate to severe (complete disabling) intensity (UPDRS item 33 rating = 2), with dyskinesias for at least 3 months before randomization, and who are on L-dopa treatment for at least 3 years prior to randomization; L-dopa treatment has to be stable for at least 1 month prior to randomization (i.e. the total daily dose and dosing regimen can vary among patients but will be the same for individual patients). Other concomitant anti-parkinsonian medication is allowed but the total daily dose and dosing regimen has to be stable for at least one month prior to randomization. Female patients must be without childbearing potential (post-menopausal or surgically sterilized); for safety reasons they have to use a double-barrier local contraception (e.g., intra-uterine device plus condom) during the entire study from screening up to the study completion visit. Male patients must be using a double-barrier local contraception for the entire duration of the study (from screening up to the study completion visit), and refrain from fathering a child in the 3 months following last study drug administration. Patients must be able to provide written informed consent prior to study participation.
- •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
- •Following patients will be excluded from the study: smokers, with a prior surgery for Parkinson’s Disease, with a Hoehn and Yahr score of 5 when ‘off’, with cognitive impairment (MMSE less than 24), with atypical Parkinson’s disease (Progressive Supranuclear Palsy (PSP), Multi Systemic Atrophy (MSA)), with history or presence of psychosis and/or confusional states, with a history or presence of nephrolithiasis, renal impairment, and/or liver disease, who participated in an anti-dyskinetic clinical study within the 6 months before randomization, who are under deep brain stimulation, who received anti-dyskinetic medication (i.e. antipsychotics, amantadine) within 15 days before randomization and/or neuroleptics during 2 months before randomization, who is unable to perform cognitive assessments (scheduled at screening) as determined by the neurocognitive test guidelines.
研究者
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