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Completed

NCT Number: NCT04683848

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NSHA-Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

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

Treatment and study plan

MT-3921

Biological

Solution for infusion; Intravenous (IV)

Other names: Unasnemab

Placebo

Biological

Solution for infusion; Intravenous (IV)

Primary outcomes

  1. Change in Upper Extremity Motor Score (UEMS)

    Time frame: Baseline and at Day 180

    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.

Secondary outcomes

  1. Change in Spinal Cord Independence Measurement (SCIM) III score

    Time frame: Baseline and at Day 180

    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.

  2. Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score

    Time frame: Baseline and at Day 180

    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.

  3. Change in Spinal Cord Ability Ruler (SCAR)

    Time frame: Baseline and at Day 180

    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.

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

    Time frame: Baseline and at Day 180

Sponsors and collaborators

Lead sponsor

Tanabe Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Dec 24, 2020
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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