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

Last updated: April 21, 2025
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Overall Status: Completed

Phase

2

Condition

Spinal Cord Injuries

Spinal Cord Disorders

Treatment

Placebo

MT-3921

Clinical Study ID

NCT04683848
MT-3921-A01
jRCT2031210320
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 subjectmust have at least 1 point of motor activity between C5 to C7)

  • UEMS ≤28 at Screening

  • Body mass index (BMI) <40

Exclusion

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

  • Any concomitant injury that interferes with the procedures and examinations requiredby study protocol, including performance, interpretation or validity of neurologicalexaminations

  • 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 orcurrent conditions that, in the judgement of the iInvestigator, may increase therisks associated with study participation

  • History of anaphylaxis or clinically significant allergic reactions to anymedication

  • 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 priorto Screening

  • Female subjects who are pregnant or lactating

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
August 27, 2021
Estimated Completion Date:
April 09, 2025

Connect with a study center

  • University of Calgary Foothills Medical Centre

    Calgary, Alberta T2N2T9
    Canada

    Site Not Available

  • NSHA-Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia B3H3A7
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1Y4E9
    Canada

    Site Not Available

  • Toronto Western Hospital

    Toronto, Ontario M5T2S8
    Canada

    Site Not Available

  • University of Saskatchewan

    Saskatoon, Saskatchewan S7N0W8
    Canada

    Site Not Available

  • Funabashi Municipal Medical Center

    Funabashi-shi, Chiba 273-0853
    Japan

    Site Not Available

  • Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER

    Izuka-shi, Fukuoka 820-8508
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu-shi, Gifu 501-1194
    Japan

    Site Not Available

  • Hokkaido Spinal Cord Injury Center

    Bibai-shi, Hokkaido 072-0015
    Japan

    Site Not Available

  • Japanese Red Cross Kobe Hospital

    Kobe-shi, Hyogo 651-0073
    Japan

    Site Not Available

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto-shi, Kumamoto 860-0008
    Japan

    Site Not Available

  • Murayama Medical Center

    Musashimurayama-shi, Tokyo 208-0011
    Japan

    Site Not Available

  • Honor Health Spine Group

    Scottsdale, Arizona 85251
    United States

    Site Not Available

  • University of Arizona & Banner University Medical Center Tucson

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of California, San Diego Health

    La Jolla, California 92307
    United States

    Site Not Available

  • University of Southern California - Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California Irvine

    Orange, California 92868
    United States

    Site Not Available

  • University of California - Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • UCSF

    San Francisco, California 94110
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94110
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UCHealth Memorial Hospital

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Craig Hospital

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Yale Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • George Washington University Hospital

    Washington, District of Columbia 22037
    United States

    Site Not Available

  • University of Florida

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33149
    United States

    Site Not Available

  • Tallahassee Neurological Clinic

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University of South Florida, Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Shepherd Center

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31405
    United States

    Site Not Available

  • The Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Carle Foundation Hospital

    Urbana, Illinois 61801
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Insight Institute of Neurosurgery & Neuroscience

    Flint, Michigan 48507
    United States

    Site Not Available

  • Spectrum Health

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Missouri - Columbia

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Saint Louis University Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cox Medical Centers

    Springfield, Missouri 65807
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Nassau University Medical Center

    East Meadow, New York 11554
    United States

    Site Not Available

  • NYC Health Hospital - Elmhurst

    Elmhurst, New York 11373
    United States

    Site Not Available

  • Zucker School of Medicine at Hofstra Northwell

    Hempstead, New York 11549
    United States

    Site Not Available

  • Mount Sinai Morningside

    New York, New York 10025
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Site Not Available

  • Atrium Health Rehabilitation & Therapy

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Wright State Physicians

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Mercy Health St. Vincent Medical Center

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Ascension St. John

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Oregon Health and Science University - Center for Health & Healing

    Portland, Oregon 97239
    United States

    Site Not Available

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center - Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Regional One Health

    Memphis, Tennessee 38103
    United States

    Site Not Available

  • Baylor Scott & White Institute for Rehabilitation

    Dallas, Texas 75246
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • JPS Health Network

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Brooke Army Medical Center in San Antonio

    Houston, Texas 78234
    United States

    Site Not Available

  • TIRR Memorial Hermann UT Health

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Site Not Available

  • University of Washington - Harborview Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Wisconsin - Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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