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)
- Conditions
- Spinal Cord Injury (SCI)
- Interventions
- Drug: Placebo
- Registration Number
- NCT04295538
- Lead Sponsor
- AbbVie
- 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, 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 18-75 years of age with a SCI will be enrolled. Approximately 54 participants will be enrolled in the study in approximately 49 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo for elezanumab Elezanumab Elezanumab Participants will receive elezanumab dose A
- Primary Outcome Measures
Name Time Method Upper Extremity Motor Score (UEMS) 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, respectively.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Spinal Cord Independence Measures (SCIM III) Self-Care Score 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 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.
Trial Locations
- Locations (41)
Thomas Jefferson University Hospital /ID# 215460
๐บ๐ธPhiladelphia, Pennsylvania, United States
National Hospital Organization Murayama Medical Center /ID# 223492
๐ฏ๐ตMusashimurayama-shi, Tokyo, Japan
Japan Organization of Occupational Health and Safety Spinal Injuries Centre /ID# 224141
๐ฏ๐ตIizuka-shi, Japan
The Chaim Sheba Medical Center /ID# 240917
๐ฎ๐ฑRamat Gan, Tel-Aviv, Israel
Hospital Universitario y Politecnico La Fe /ID# 217797
๐ช๐ธValencia, Spain
Duke Cancer Center /ID# 216888
๐บ๐ธDurham, North Carolina, United States
Oregon Medical Research Center /ID# 227371
๐บ๐ธPortland, Oregon, United States
Hospital Universitario 12 de Octubre /ID# 225354
๐ช๐ธMadrid, Spain
Shepherd Center, Inc /ID# 230370
๐บ๐ธAtlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 218009
๐บ๐ธChicago, Illinois, United States
Tufts Medical Center /ID# 225410
๐บ๐ธBoston, Massachusetts, United States
Boston University School of Medicine /ID# 218371
๐บ๐ธBoston, Massachusetts, United States
Brigham & Women's Hospital /ID# 216342
๐บ๐ธBoston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 218149
๐บ๐ธBoston, Massachusetts, United States
Washington University-School of Medicine /ID# 215325
๐บ๐ธSaint Louis, Missouri, United States
Hackensack Univ Med Ctr /ID# 215754
๐บ๐ธHackensack, New Jersey, United States
Rutgers New Jersey School of Medicine /ID# 216212
๐บ๐ธNewark, New Jersey, United States
Jersey Shore University Medical Center /ID# 218162
๐บ๐ธNeptune, New Jersey, United States
University of Pennsylvania /ID# 218662
๐บ๐ธPhiladelphia, Pennsylvania, United States
University of Virginia Health /ID# 218117
๐บ๐ธCharlottesville, Virginia, United States
Sentara Norfolk General Hospital /ID# 218302
๐บ๐ธNorfolk, Virginia, United States
West Virginia University Hospitals /ID# 217344
๐บ๐ธMorgantown, West Virginia, United States
Royal Adelaide Hospital /ID# 216953
๐ฆ๐บAdelaide, South Australia, Australia
QEII - Health Sciences Centre /ID# 215249
๐จ๐ฆHalifax, Nova Scotia, Canada
Toronto Western Hospital /ID# 215214
๐จ๐ฆToronto, Ontario, Canada
The Ottawa Hospital Civic Campus /ID# 215270
๐จ๐ฆOttawa, Ontario, Canada
Foothills Medical Centre /ID# 214790
๐จ๐ฆCalgary, Alberta, Canada
Funabashi Municipal Medical Center /ID# 225599
๐ฏ๐ตFunabashi-shi, Chiba, Japan
NHO Nagoya Medical Center /ID# 239617
๐ฏ๐ตNagoya-shi, Aichi, Japan
CIUSSS du Nord-de-l'ile-de-Montrรฉal_Hopital du Sacrรฉ-Coeur de Montrรฉal /ID# 215210
๐จ๐ฆMontreal, Quebec, Canada
Duplicate_Inha University Hospital /ID# 238890
๐ฐ๐ท์ค๊ตฌ, Incheon Gwang Yeogsi, Korea, Republic of
Complejo Hospitalario Universitario A Coruรฑa /ID# 216384
๐ช๐ธA Coruรฑa, A Coruna, Spain
Ajou University Hospital /ID# 241119
๐ฐ๐ทSuwon-si, Gyeonggido, Korea, Republic of
Hospital Universitario Virgen del Rocio /ID# 225692
๐ช๐ธSevilla, Spain
Hospital Universitario Vall d'Hebron /ID# 217794
๐ช๐ธBarcelona, Spain
Hospital Nacional de Paraplejicos /ID# 225508
๐ช๐ธToledo, Spain
University of California Davis Health /ID# 224892
๐บ๐ธSacramento, California, United States
University of Louisville Hospital /ID# 215948
๐บ๐ธLouisville, Kentucky, United States
Regents of the University of Michigan /ID# 215890
๐บ๐ธAnn Arbor, Michigan, United States
Virginia Commonwealth University Medical Center Main Hospital /ID# 217481
๐บ๐ธRichmond, Virginia, United States
Wisconsin Medical Center /ID# 215610
๐บ๐ธMilwaukee, Wisconsin, United States