Clareo Health | Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)
Safety And Efficacy Study Of Intravenous (IV) Administration Of Elezanumab To Assess Change In Upper Extremity Motor Score (UEMS) In Adult Participants With Acute Traumatic Cervical Spinal Cord Injury (SCI)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Acute traumatic cervical spinal cord injury (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.
Participants with comorbid conditions that, in the investigator's opinion, are clinically stable and not expected to meaningfully progress in the following 12 months, may be considered eligible to participate.
You may not be if
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 International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
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.
