Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
NCT ID: NCT04683848
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2021-08-27
2025-04-09
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-3921
Intravenous (IV)
MT-3921
Solution for infusion; Intravenous (IV)
Placebo
Intravenous (IV)
Placebo
Solution for infusion; Intravenous (IV)
Interventions
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MT-3921
Solution for infusion; Intravenous (IV)
Placebo
Solution for infusion; Intravenous (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Tanabe Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Head of Medical Science
Role: STUDY_DIRECTOR
Tanabe Pharma America, Inc.
Locations
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University of California Irvine
Orange, California, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Augusta University
Augusta, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Spectrum Health
Grand Rapids, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Louis University Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Carolinas Rehabilitation
Charlotte, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Oregon Health and Science University - Center for Health & Healing
Portland, Oregon, United States
Brooke Army Medical Center in San Antonio
Houston, Texas, United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Carilion Clinic
Roanoke, Virginia, United States
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, United States
NSHA-Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER
Izuka-shi, Fukuoka, Japan
Gifu University Hospital
Gifu, Gifu, Japan
Hokkaido Spinal Cord Injury Center
Bibai-shi, Hokkaido, Japan
Japanese Red Cross Kobe Hospital
Kobe, Hyōgo, Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, Kumamoto, Japan
Murayama Medical Center
Musashimurayama-shi, Tokyo, Japan
Countries
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Other Identifiers
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jRCT2031210320
Identifier Type: REGISTRY
Identifier Source: secondary_id
MT-3921-A01
Identifier Type: -
Identifier Source: org_study_id