Elezanumab for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Spinal Cord InjuryElezanumab - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is being done to find out if elezanumab is safe and to see if it improves motor function in people with acute cervical SCI.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 52 Weeks

52 Weeks
Upper Extremity Motor Score (UEMS)
Week 52
Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score
Change in Upper Extremity Motor Score (UEMS) From Baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Elezanumab
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

54 Total Participants · 2 Treatment Groups

Primary Treatment: Elezanumab · Has Placebo Group · Phase 2

Elezanumab
Drug
Experimental Group · 1 Intervention: Elezanumab · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks

Who is running the clinical trial?

AbbVieLead Sponsor
836 Previous Clinical Trials
471,695 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
305 Previous Clinical Trials
119,129 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The text states that the study drug can be administered within 24 hours of the injury.
Maximum screening for UEMS of 32.
The text states that if someone has an American Spinal Injury Association Impairment Scale (AIS) grade of A or B at screening, they are likely to have a good prognosis.
This is a person who has had a significant injury to their cervical spinal cord- the fourth, fifth, sixth, or seventh cervical vertebra- that has not impact their thoracic (between the chest and stomach) or lumbar (lower back) regions and, in the doctor's opinion, will significantly limit their recovery.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Shepherd Center, Inc /ID# 230370100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%