Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Keywords

Spinal Cord Injury Spinal Cord Injuries Wounds and Injuries

Eligibility

You can join if…

Open to people ages 18-70

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

You CAN'T join if...

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

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94110 United States
  • Stanford University not yet accepting patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mitsubishi Tanabe Pharma Development America, Inc.
ID
NCT04683848
Phase
Phase 2
Study Type
Interventional
Last Updated