Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Spinal Cord Injury (SCI)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment and sudden disability. Approximately 25,000 people experience cervical SCI in the United States, Europe, a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04295538
Start Date
September 6 2020
End Date
January 1 2026
Last Update
July 4 2025
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Davis Health /ID# 224892
Sacramento, California, United States, 95817
2
Shepherd Center, Inc /ID# 230370
Atlanta, Georgia, United States, 30309-1426
3
Northwestern University Feinberg School of Medicine /ID# 218009
Chicago, Illinois, United States, 60611-2927
4
University of Louisville Hospital /ID# 215948
Louisville, Kentucky, United States, 40202