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

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

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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