[M16-077] 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

JRCT ID: jRCT2031210009

Registered date:02/04/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Acute Traumatic Cervical Spinal Cord Injury
• Date of first enrollment: 27/11/2020
• Target sample size: 54
• Countries of recruitment: Australia,Japan,Canada,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Elezanumab
Solution for infusion; Intravenous (IV)
Other Name: ABT-555

Drug: Placebo
Solution for infusion; Intravenous (IV)

Outcome(s)

Primary Outcome

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.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

Acute traumatic cervical 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.

Exclude criteria

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 ISNCSCI examination.
Known history prior to randomization of clinically significant medical or surgical conditions (other than current acute SCI) or any other reason, including any physical, psychological, or psychiatric condition that in the opinion of the Investigator would compromise the safety or interfere with the participant's participation in this study, or would make the participant an unsuitable candidate to receive study drug, or would put the participant at risk by participating in the study, including history of or abnormal screening lab or imaging results that, in the opinion of the investigator, are indicative of any irreparable cardiac, endocrinologic, hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic, and/or other major disease that would preclude administration of elezanumab.
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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT04295538