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MT-3921 for Spinal Cord Injury

Phase 2
Waitlist Available
Research Sponsored by Mitsubishi Tanabe Pharma America Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Classified as AIS A, AIS B or AIS C
UEMS ≤28 at Screening
Must not have
Subjects with hereditary fructose intolerance
Complete transection of the spinal cord
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at day 180

Summary

This trial is testing a new drug to see if it is effective and safe for people with a specific type of spinal cord injury.

Who is the study for?
This trial is for adults with a recent traumatic injury to the neck part of their spinal cord, classified as AIS A, B, or C. They must have some motor activity left in certain areas and a body mass index under 40. Excluded are those with severe other injuries, complete spinal cord cuts, significant pre-existing conditions, drug abuse issues, pregnancy or lactation among women.
What is being tested?
The study tests MT-3921 against a placebo in people who've just had a serious neck spinal cord injury. Participants will be randomly assigned to receive either the real treatment or placebo via IV infusion over six months without knowing which one they're getting.
What are the potential side effects?
While specific side effects aren't listed here, participants may experience reactions related to intravenous infusions such as discomfort at the injection site or allergic reactions if sensitive to components within MT-3921.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My spinal injury is classified as AIS A, B, or C.
Select...
My upper body strength score is 28 or less.
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My spinal cord injury is between my neck and mid-back, with some arm movement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have hereditary fructose intolerance.
Select...
My spinal cord is completely severed.
Select...
I have a penetrating injury to my spinal cord.
Select...
I am currently pregnant or breastfeeding.
Select...
I have had a severe injury with an ISS score over 25.
Select...
I currently have COVID-19.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at day 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at day 180 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Upper Extremity Motor Score (UEMS)
Secondary study objectives
Change in Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) score
Change in Spinal Cord Ability Ruler (SCAR)
Change in Spinal Cord Independence Measurement (SCIM) III score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MT-3921Experimental Treatment1 Intervention
Intravenous (IV)
Group II: PlaceboPlacebo Group1 Intervention
Intravenous (IV)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MT-3921
2022
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Mitsubishi Tanabe Pharma America Inc.Lead Sponsor
26 Previous Clinical Trials
3,230 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,560 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,414 Total Patients Enrolled

Media Library

MT-3921 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04683848 — Phase 2
Spinal Cord Injury Research Study Groups: Placebo, MT-3921
Spinal Cord Injury Clinical Trial 2023: MT-3921 Highlights & Side Effects. Trial Name: NCT04683848 — Phase 2
MT-3921 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04683848 — Phase 2
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT04683848 — Phase 2
~2 spots leftby Jan 2025
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