Have you or your loved ones been diagnosed with spinal cord injury?

You may be eligible to participate in a spinal cord injury clinical trial.

Have you or your loved ones been diagnosed with spinal cord injury? You may be eligible to participate in a spinal cord injury clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Spinal Cord Injury Clinical Trial

NCT04683848 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with spinal cord injury?

You may be eligible to participate in a spinal cord injury clinical trial.

Have you or your loved ones been diagnosed with spinal cord injury? You may be eligible to participate in a spinal cord injury clinical trial.

Recruiting

Male & Female

18 - 75

Years old

This study is looking to recruit 72 Participants

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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Details for the study

Brief Title

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

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

Brief Summary

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions <br /> of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury. <br /> <br /> Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects <br /> will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

Treatments and/or Procedures

MT 3921

Solution for infusion; Intravenous (IV)

Placebo

Solution for infusion; Intravenous (IV)

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Change in Upper Extremity Motor Score (UEMS)

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.

Baseline and at Day 180

Secondary

Change in Spinal Cord Independence Measurement (SCIM) III score

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.

Baseline and at Day 180

Secondary

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

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.

Baseline and at Day 180

Secondary

Change in Spinal Cord Ability Ruler (SCAR)

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.

Baseline and at Day 180

Study 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