EUCTR2018-004892-11-IT进行中（未招募）1 期
A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients - SteP-on
OSPEDALE SANTA MARIA DELLA MISERICORDIA0 个研究点目标入组 128 人开始时间: 2020年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
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
- •Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD according to UK Brain Bank diagnostic criteria;
- •A Modified Hoehn and Yahr stage of = 4 in the off” state;
- •A stable (4 weeks since last modification) anti-parkinsonian therapy, always including levodopa (L- dopa)/dopa-decarboxylase inhibitor (DDI);
- •1 month wash out is needed if patient received other MAO-B inhibitors;
- •The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs frozen” or glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0)
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 58
排除标准
- •Subjects with other severe neurological or systemic concomitant conditions, sensory deficits, clear signs of peripheral neuropathy or orthopaedic comorbidities which may interfere with gait;
- •Patients for whom Safinamide is contraindicated according to the current SmPC.
- •Female subjects with ongoing or lactating or fertile pregnancy who do not adopt or intend to use adequate methods of contraception for the duration of the study. Individuals who agree to use a reliable contraceptive method during the study will be admitted (for example: more prophylactic oral contraceptive, intrauterine device (DIU or IUD) more prophylactic, diaphragm with more prophylactic spermicide). Subjects with sterile partners (eg vasectomy) and menopausal subjects for at least 1 year or surgically sterile may be included in the study.
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