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)
About this trial
This is a study enrolling individuals with new (less than 24 hours) cervical (neck area) spinal cord injuries to test the safety and effectiveness of an experimental drug called elezanumab. Elezanumab is a protein in the body that is able to neutralize a molecule that inhibits nerve regeneration after SCI, thus allowing nerve growth and possible functional recovery. The study includes two groups, one receiving elezanumab, the other receiving a placebo (an inactive drug used to compare the groups). This study is double-blinded, which means that neither trial participants nor the study doctors will know who will be given which study drug. If selected for the trial, participants will have a 2 in 3 chance to be in the group receiving the drug, or 1 in 3 chance to be in the group receiving a placebo. This study will compare the groups and measure any changes in arm and hand function.
Included participants
Traumatic
What’s involved
Type
Details
Injection of the antibody, into a vein, within 24 hours of the spinal cord injury Injection of the antibody, into a vein, every 4 weeks for a total of 13 doses (48 weeks) Medical assessments, blood tests, checking for side effects and completing questionnaires
Potential benefits
Main benefits
Arm/hand function
Additional benefits
General health
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Active
- Trial start date
- 6 Sep 2020
- Organisation
- AbbVie
- Trial recruitment status
- Active
- Trial start date
- 6 Sep 2020
- Organisation
- AbbVie
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more