CompletedPhase 2
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Key facts
- Who runs it
- Tanabe Pharma America, Inc.
- Where
- Augusta, Charlotte, Cincinnati, Grand Rapids, Houston, Jackson, Lexington, Milwaukee, Omaha, Orange, Portland, Roanoke, San Antonio, St Louis, and Tallahassee, United StatesSee the 15 sitesAlso in 2 other countries, 8 sites
- Trial code
- NCT04683848
- JRCT2031210320
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 72 people enrolled
- Started
- 27 Aug 2021
- Ended
- 9 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- MT-3921
- Placebo
- Record updated
- 16 December 2025
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
- 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 or presence of malignancy within the last 3 years prior to screening
- Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
- History of anaphylaxis or clinically significant allergic reactions to any medication
- Subjects with current SARS-CoV-2 infection (COVID-19)
- Psychoactive substance use disorder
- Additional screening criteria check may apply for qualification:
- Poly-traumatic Injury as defined by Injury Severity Score (ISS) values > 25
- Penetrating spinal cord injuries
- Complete transection of the spinal cord
- Subjects with hereditary fructose intolerance
- Female subjects who are pregnant or lactating
Where in United States
Also in 2 other countries, 8 sites
- Augusta UniversityAugusta, United StatesNo longer taking part
- Carolinas RehabilitationCharlotte, United StatesNo longer taking part
- University of CincinnatiCincinnati, United StatesNo longer taking part
- Spectrum HealthGrand Rapids, United StatesNo longer taking part
- Brooke Army Medical Center in San AntonioHouston, United StatesNo longer taking part
- University of Mississippi Medical CenterJackson, United StatesNo longer taking part
- University of KentuckyLexington, United StatesNo longer taking part
- Medical College of Wisconsin/ Froedtert HospitalMilwaukee, United StatesNo longer taking part
- University of Nebraska Medical CenterOmaha, United StatesNo longer taking part
- University of California IrvineOrange, United StatesNo longer taking part
- Oregon Health and Science University - Center for Health & HealingPortland, United StatesNo longer taking part
- Carilion ClinicRoanoke, United StatesNo longer taking part
- The University of Texas Health Science Center at San AntonioSan Antonio, United StatesNo longer taking part
- Saint Louis University HospitalSt Louis, United StatesNo longer taking part
- Tallahassee Neurological ClinicTallahassee, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- MT-3921Treatment being tested
Intravenous (IV)
- PlaceboPlacebo, for comparison
Intravenous (IV)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 16 December 2025