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

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Enrolling
Phase 2

Conditions

Spinal Cord Injury

Treatments

Biological: Placebo
Biological: MT-3921

Study type

Interventional

Funder types

Industry

Identifiers

NCT04683848
jRCT2031210320 (Registry Identifier)
MT-3921-A01

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

MT-3921
Experimental group
Description:
Intravenous (IV)
Treatment:
Biological: MT-3921
Placebo
Placebo Comparator group
Description:
Intravenous (IV)
Treatment:
Biological: Placebo

Trial contacts and locations

64

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Central trial contact

Clinical Trials Information Desk, to prevent miscommunication,

Data sourced from clinicaltrials.gov

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