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

  • STATUS
    Recruiting
  • End date
    Apr 19, 2023
  • participants needed
    72
  • sponsor
    Mitsubishi Tanabe Pharma Development America, Inc.
Updated on 22 August 2021
Investigator
Clinical Trials Information Desk, to prevent miscommunication,
Primary Contact
NSHA-Queen Elizabeth II Health Sciences Centre (0.6 mi away) Contact
+62 other location
body mass index
spinal cord
cervical spinal cord injury
spinal cord disorder

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.

Details
Condition Spinal Cord Injury, Myelopathy, Trauma
Treatment Placebo, MT-3921
Clinical Study IdentifierNCT04683848
SponsorMitsubishi Tanabe Pharma Development America, Inc.
Last Modified on22 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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