JPRN-jRCT2031210009招募中2 期
[M16-077] A Randomized, Double-Blind, Placebo-Controlled Proof of Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Traumatic Cervical Spinal Cord Injury
Otani Tetsuya0 个研究点目标入组 54 人开始时间: 2021年4月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
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
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator's opinion, would significantly limit recovery.
- •Maximum screening UEMS of 32.
- •American Spinal Injury Association Impairment Scale (AIS) grade A or B at Screening.
- •Able to initiate study drug administration within 24 hours of injury.
排除标准
- •Evidence of complete spinal cord transection.
- •Significant concomitant head injury with a clinically significant abnormality on a head computed tomography (CT).
- •One or more upper extremity muscle groups untestable (e.g., immobilized or restricted by a cast) during the screening ISNCSCI examination.
- •Known history prior to randomization of clinically significant medical or surgical conditions (other than current acute SCI) or any other reason, including any physical, psychological, or psychiatric condition that in the opinion of the Investigator would compromise the safety or interfere with the participant's participation in this study, or would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study, including history of or abnormal screening lab or imaging results that, in the opinion of the investigator, are indicative of any irreparable cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major disease that would preclude administration of elezanumab.
- •Known receipt of any other investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study.
- •Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for within 39 weeks (5 half-lives) after the last dose of study drug.
- •The cause of the acute SCI is one of the following: from gunshot or penetrating/stab wound; non-traumatic SCI, results of seizure, or known attempted suicide.
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