EUCTR2021-001988-24-PL进行中（未招募）1 期
Prospective, randomized, double-blind, placebo-controlled, parallel-group trial with an open-label period to investigate the efficacy and safety of NT201 in the unilateral and bilateral treatment of essential tremor of the upper limb
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Score of = 2 (at least 1 cm tremor amplitude) in at least two out of three maneuvers of test item 4 (upper limb tremor) confirmed by an independent
- •TETRAS expert by means of video assessment.
- •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 43
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •History or presence of day-to-day fluctuations in ET which would jeopardize meaningful tremor assessment over time, e.g. severe tremor on one day
- •and minimal or no tremor on another day.
- •Other neurological signs, such as dystonia, ataxia, or parkinsonism, which in the judgment of the investigator could interfere with the ET diagnosis
- •and/or assessment of ET in ULs.
- •Tremor types other than ET
研究者
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