BioAxone BioSciences, Inc., Cambridge, MA, USA.
McGill University, Department of Neurology and Neurosurgery, Montreal, Quebec, Canada ; BioAxone BioSciences, Inc., Cambridge, MA, USA.
Neural Regen Res. 2014 Aug 15;9(16):1493-7. doi: 10.4103/1673-5374.139470.
Cervical spinal cord injury (SCI) results in partial to full paralysis of the upper and lower extremities. Traditional primary endpoints for acute SCI clinical trials are too broad to assess functional recovery in cervical subjects, raising the possibility of false positive outcomes in trials for cervical SCI. Endpoints focused on the recovery of hand and arm control (e.g., upper extremity motor score, motor level change) show the most potential for use as primary outcomes in upcoming trials of cervical SCI. As the field moves forward, the most reliable way to ensure meaningful clinical testing in cervical subjects may be the development of a composite primary endpoint that measures both neurological recovery and functional improvement.
颈椎脊髓损伤 (SCI) 会导致上肢和下肢部分或完全瘫痪。传统的急性 SCI 临床试验的主要终点过于广泛，无法评估颈椎患者的功能恢复情况，这增加了颈椎 SCI 临床试验出现假阳性结果的可能性。侧重于手部和手臂控制恢复的终点（例如，上肢运动评分、运动水平变化）最有可能成为即将进行的颈椎 SCI 临床试验的主要终点。随着该领域的发展，确保在颈椎患者中进行有意义的临床测试的最可靠方法可能是开发一种衡量神经恢复和功能改善的综合主要终点。
