Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Tanabe Pharma America, Inc.72 enrolled

Overview

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Spinal Cord Injury

Interventions

MT-3921BIOLOGICAL

Solution for infusion; Intravenous (IV)

PlaceboBIOLOGICAL

Solution for infusion; Intravenous (IV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: Additional screening criteria check may apply for qualification: * Provide written informed consent prior to beginning any study procedures * Cervical spinal cord injury that meet all of the following criteria: * Classified as AIS A, AIS B or AIS C * ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7) * UEMS ≤28 at Screening * Body mass index (BMI) \<40 Exclusion Criteria: Additional screening criteria check may apply for qualification: * Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations * Poly-traumatic Injury as defined by Injury Severity Score (ISS) values \> 25 * Penetrating spinal cord injuries * Complete transection of the spinal cord * Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation * History of anaphylaxis or clinically significant allergic reactions to any medication * History or presence of malignancy within the last 3 years prior to screening * Subjects with current SARS-CoV-2 infection (COVID-19) * Subjects with hereditary fructose intolerance * Psychoactive substance use disorder * Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening * Female subjects who are pregnant or lactating

Locations (23)

University of California Irvine

Orange, California, United States

Outcomes

Primary Outcomes

Change in Upper Extremity Motor Score (UEMS)

The UEMS is a subscore of the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) that focuses selectively on function of 5 key muscles in the upper limbs. UEMS ranges from 0 to 50 points, where a higher score indicates a better movement.