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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04683848
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma America Inc.

Study Description
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Brief 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. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Biological: MT-3921 Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MT-3921
Intravenous (IV)
 Biological: MT-3921
Solution for infusion; Intravenous (IV)
Other Name: Unasnemab
Placebo Comparator: Placebo
Intravenous (IV)
 Biological: Placebo
Solution for infusion; Intravenous (IV)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683848


Contacts
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Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: information@mt-pharma-us.com

Locations
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Sponsors and Collaborators
Mitsubishi Tanabe Pharma America Inc.
Investigators
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Study Director: Head of Medical Science Mitsubishi Tanabe Pharma America Inc.
More Information
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Responsible Party: Mitsubishi Tanabe Pharma America Inc.
ClinicalTrials.gov Identifier: NCT04683848    
Other Study ID Numbers: MT-3921-A01
jRCT2031210320 ( Registry Identifier: Japan Registry of Clinical Trials (jRCT) )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System