The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve function in patients with acute traumatic cervical spinal cord injury (SCI).
AbbVie ELASCI
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
Spine injuries and disorders
All genders
18-70
Recruiting now
Overview
Principal Investigator: Deborah Green-LaRoche, MD
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Neuro Research
Study details
Inclusion Criteria
- Acute traumatic cervical SCI, neurological level of injury of C4, C5, C6, or C7 (cervical lesion as defined by first ISNCSCI) with no damage to cord in thoracic (T2 and beyond) and lumbar regions that, in the investigator's opinion, would significantly limit recovery.
- In the investigator's opinion, subject is likely to be available for follow-up for the duration of the study (e.g., fixed home address).
- Subjects are willing and able to comply with procedures required in this protocol.
Exclusion Criteria
- The cause of the acute SCI was not any of the following: from gunshot or penetrating/stabwound; non-traumatic SCI (e.g., central cord syndrome, transverse myelitis, acute disc herniation in the absence of trauma, ischemia), result of seizure, or known attempted suicide.
- No significant head injury with a clinically significant abnormality on a head computed tomography (CT).
- Absence of complete spinal cord transection.
Study Requirements
You will begin the study procedures during your inpatient stay at Tufts Medical Center and then asked to come for 14 visits at the study site, after discharge from the hospital, over the period of about 1 year and 6 months. After the last infusion of study drug (Week 48), you will come to the site for two more post intervention visits (Week 52 and Post-Intervention Week 24). The study procedures include physical and neurological exams, taking of your vital signs (blood pressure, heart rate, and temperature), ECGs (a test which records the electrical activity of your heart), urine tests for illegally used drugs and alcohol abuse, CT Scan and MRIs (tests to make pictures of your brain), blood draws, and several assessments and scales.