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) (ELASCI)
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|ClinicalTrials.gov Identifier: NCT04295538|
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : February 21, 2021
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, and Japan every year. The purpose of this study is to see if elezanumab is safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute traumatic cervical SCI.
Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded", which means that neither trial participants nor the study doctors will know who will be given which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Participants 18-70 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 36 sites worldwide.
Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of injury and every 4 weeks thereafter through Week 48 for a total of 13 doses.
There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury (SCI)||Drug: Elezanumab Drug: Placebo||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||September 6, 2020|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Participants will receive elezanumab dose A
Solution for infusion; Intravenous (IV)
Other Name: ABT-555
Placebo Comparator: Placebo
Participants will receive placebo for elezanumab
Solution for infusion; Intravenous (IV)
- Upper Extremity Motor Score (UEMS) [ Time Frame: 52 Weeks ]The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement.
- Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score [ Time Frame: Week 0 through Week 52 ]The SCIM III self-care score addresses four areas of self-care management: feeding, grooming, bathing, and dressing. It has a total of 4 questions. Scores range from 0-20 where a score of 0 defines total dependence and 20 is indicative of complete independence.
- Change in Upper Extremity Motor Score (UEMS) From Baseline [ Time Frame: Week 0 through Week 52 ]The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that grades function of 5 key muscles in the upper limbs on a scale of 0 to 5 on each side from total paralysis to active full range of movement, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04295538
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||AbbVie Inc.||AbbVie|