Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Completed · Phase 2 · Has a placebo group
Conditions studied: Spinal Cord Injury
In brief
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.
Key facts
- Study ID
- NCT04683848
- Run by
- Tanabe Pharma America, Inc.
- People needed
- 72
- Starts
- 2021-08-27
- Expected to finish
- 2025-04-09
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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