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Spinal Cord InjuryPhase 2NCT04683848

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

A Phase 2 study testing MT-3921 in people with Spinal Cord Injury, run by Tanabe Pharma America, Inc. at 23 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
MT-3921
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
23 sitesin 3 countries
Study dates
27 Aug 2021to 9 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

23 sites in 3 countries.

23 sites in 3 countries

United States15 sites

  • Augusta University

    Augusta, Georgia, 30912

  • Carolinas Rehabilitation

    Charlotte, North Carolina, 28203

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Brooke Army Medical Center in San Antonio

    Houston, Texas, 78234

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Medical College of Wisconsin - Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California Irvine

    Orange, California, 92868

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

    Portland, Oregon, 97239

  • Carilion Clinic

    Roanoke, Virginia, 24014

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Saint Louis University Hospital

    St Louis, Missouri, 63110

  • Tallahassee Neurological Clinic

    Tallahassee, Florida, 32308

Other trials in United States

Japan6 sites

  • Hokkaido Spinal Cord Injury Center

    Bibai-shi, Hokkaido, 072-0015

  • Gifu University Hospital

    Gifu, Gifu, 501-1194

  • Japan Organization of Occupational Health and Safety SPINAL INJURIES CENTER

    Izuka-shi, Fukuoka, 820-8508

  • Japanese Red Cross Kobe Hospital

    Kobe, Hyōgo, 651-0073

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Kumamoto, 860-0008

  • Murayama Medical Center

    Musashimurayama-shi, Tokyo, 208-0011

Other trials in Japan

Canada2 sites

  • NSHA-Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H3A7

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y4E9

Other trials in Canada

About this study

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

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.

Being tested
MT-3921, Placebo
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MT-3921Biological

    Also called Unasnemab

    Solution for infusion; Intravenous (IV)

  • PlaceboBiological

    Solution for infusion; Intravenous (IV)

Study groups in NCT04683848
Study groupRoleWhat they receive
MT-3921ExperimentalIntravenous (IV)
Receives: Biological: MT-3921
PlaceboPlacebo comparatorIntravenous (IV)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and at Day 180

Secondary outcomes (4)

  1. 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.

    Measured: Baseline and at Day 180

  2. 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.

    Measured: Baseline and at Day 180

  3. 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.

    Measured: Baseline and at Day 180

  4. Proportion of responders (i.e., subjects with cutoff number or greater increase in the UEMS compared to baseline)

    Measured: Baseline and at Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start27 Aug 2021
  3. Primary completion24 Dec 2024
  4. Study completion9 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683848
Sponsor's protocol ID
MT-3921-A01
Other IDs
jRCT2031210320
Status last verified
Dec 2025
First submitted
20 Dec 2020
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MT-3921 in people with Spinal Cord Injury, run by Tanabe Pharma America, Inc. at 23 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Japan, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Upper Extremity Motor Score (UEMS) (time frame: Baseline and at Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04683848.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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