NCT02542787已完成2 期
A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Numerical Rating Scale
研究概览
简要总结
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.
详细描述
Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of MS
- •Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening.
- •Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH
排除标准
- •Acute MS relapse requiring treatment with steroids within 30 days of screening.
- •Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening.
- •Receiving medications that would potentially interfere with the actions of the study medication or outcome variables
- •Significant renal and hepatic abnormalities
- •Previous history of other significant medical disorders
研究组 & 干预措施
Active
Experimental
VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days
干预措施: VSN16R (Drug)
Placebo
Placebo Comparator
Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days
干预措施: Placebo (Other)
结局指标
主要结局
Numerical Rating Scale
时间窗: 26 days
次要结局
- Modified Ashworth Scale(26 days)
研究者
研究点 (4)
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