NCT04683848已完成2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 23
- 主要终点
- Change in Upper Extremity Motor Score (UEMS)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury.
Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Additional screening criteria check may apply for qualification:
- •Provide written informed consent prior to beginning any study procedures
- •Cervical spinal cord injury that meet all of the following criteria:
- •Classified as AIS A, AIS B or AIS C
- •ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)
- •UEMS ≤28 at Screening
- •Body mass index (BMI) <40
排除标准
- •Additional screening criteria check may apply for qualification:
- •Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
- •Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
- •Penetrating spinal cord injuries
- •Complete transection of the spinal cord
- •Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
- •History of anaphylaxis or clinically significant allergic reactions to any medication
- •History or presence of malignancy within the last 3 years prior to screening
- •Subjects with current SARS-CoV-2 infection (COVID-19)
- •Subjects with hereditary fructose intolerance
- •Psychoactive substance use disorder
- •Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
MT-3921
Experimental
Intravenous (IV)
干预措施: MT-3921 (Biological)
Placebo
Placebo Comparator
Intravenous (IV)
干预措施: Placebo (Biological)
结局指标
主要结局
Change in Upper Extremity Motor Score (UEMS)
时间窗: Baseline and at Day 180
The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that focuses selectively on function of 5 key muscles in the upper limbs. UEMS ranges from 0 to 50 points, where a higher score indicates a better movement.
次要结局
- Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score(Baseline and at Day 180)
- Change in Spinal Cord Ability Ruler (SCAR)(Baseline and at Day 180)
- Change in Spinal Cord Independence Measurement (SCIM) III score(Baseline and at Day 180)
- Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)(Baseline and at Day 180)
研究者
研究点 (23)
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