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

Spinal Cord Injury Clinical Trial

Official title:

A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04683848
• Other study ID #: MT-3921-A01
• Secondary ID: jRCT2031210320
• Status: Recruiting
• Phase: Phase 2
• Start date: August 27, 2021
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Mitsubishi Tanabe Pharma America Inc.
• Contact: Clinical Trials Information Desk, to prevent miscommunication,
• Phone: please email:
• Email: information[@]mt-pharma-us.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Biological:
• MT-3921
Solution for infusion; Intravenous (IV)
• Placebo
Solution for infusion; Intravenous (IV)

Locations

Country	Name	City	State
Canada	University of Calgary Foothills Medical Centre	Calgary	Alberta
Canada	NSHA-Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Toronto Western Hospital	Toronto	Ontario
Japan	Hokkaido Spinal Cord Injury Center	Bibai-shi	Hokkaido
Japan	Funabashi Municipal Medical Center	Funabashi-shi	Chiba
Japan	Gifu University Hospital	Gifu-shi	Gifu
Japan	Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER	Izuka-shi	Fukuoka
Japan	Japanese Red Cross Kobe Hospital	Kobe-shi	Hyogo
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto-shi	Kumamoto
Japan	Murayama Medical Center	Musashimurayama-shi	Tokyo
United States	Albany Medical Center	Albany	New York
United States	Shepherd Center	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Atrium Health Rehabilitation & Therapy	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	UCHealth Memorial Hospital	Colorado Springs	Colorado
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Baylor Scott & White Institute for Rehabilitation	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Nassau University Medical Center	East Meadow	New York
United States	NYC Health Hospital - Elmhurst	Elmhurst	New York
United States	Craig Hospital	Englewood	Colorado
United States	Insight Institute of Neurosurgery & Neuroscience	Flint	Michigan
United States	JPS Health Network	Fort Worth	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Vidant Medical Center	Greenville	North Carolina
United States	Brooke Army Medical Center in San Antonio	Houston	Texas
United States	TIRR Memorial Hermann UT Health	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Kentucky	Lexington	Kentucky
United States	University of Southern California - Keck School of Medicine	Los Angeles	California
United States	Regional One Health	Memphis	Tennessee
United States	Medical College of Wisconsin - Froedtert Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	Yale Medicine	New Haven	Connecticut
United States	Louisiana State University Health Sciences Center	New Orleans	Louisiana
United States	Mount Sinai Morningside	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California Irvine	Orange	California
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center - Presbyterian	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University - Center for Health & Healing	Portland	Oregon
United States	Carilion Clinic	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	UCSF	San Francisco	California
United States	University of California, San Francisco	San Francisco	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Honor Health Spine Group	Scottsdale	Arizona
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	University of South Florida, Tampa General Hospital	Tampa	Florida
United States	Mercy Health St. Vincent Medical Center	Toledo	Ohio
United States	Ascension St. John	Tulsa	Oklahoma
United States	Carle Foundation Hospital	Urbana	Illinois
United States	George Washington University Hospital	Washington	District of Columbia
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Countries where clinical trial is conducted

United States,  Canada,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at Day 180
Secondary	Change in Spinal Cord Independence Measurement (SCIM) III score	The SCIM III is a comprehensive rating scale that measures the ability of patients with SCI to perform everyday tasks according to their value for the patient. The SCIM III is grouped into four subscales: Self-Care, Respiration and Sphincter Management, Mobility in Room and Toilet, and Mobility Indoors and Outdoors. The total SCIM III score ranges from 0 to 100 points, with 0 point being requiring total assistance and 100 points being completely independent.	Baseline and at Day 180
Secondary	Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score	The GRASSP measures sensorimotor and prehension function through three domains (Strength, Sensation and Prehension) which are important in describing arm and hand function. The total GRASSP score ranges from 0 to 116 points, where a higher score indicates a better outcome.	Baseline and at Day 180
Secondary	Change in Spinal Cord Ability Ruler (SCAR)	The SCAR measures voluntary task specific physical actions contributing to independence in ability of daily living. The SCAR uses select items from the upper limb motor assessments of the ISNCSCI and the SCIM III.	Baseline and at Day 180
Secondary	Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)		Baseline and at Day 180