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Neural Regen Res. 2014 Aug 15;9(16):1493-7. doi: 10.4103/1673-5374.139470.

Cervical spinal cord injury: tailoring clinical trial endpoints to reflect meaningful functional improvements.

Author information

1
BioAxone BioSciences, Inc., Cambridge, MA, USA.
2
McGill University, Department of Neurology and Neurosurgery, Montreal, Quebec, Canada ; BioAxone BioSciences, Inc., Cambridge, MA, USA.

Abstract

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.

KEYWORDS:

Cethrin; SCI; UEMS; cervical; clinical trial; endpoint; spinal cord injury

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