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MT-3921 for Spinal Cord Injury

Phase 2
Recruiting
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
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
Classified as AIS A, AIS B or AIS C
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at day 180
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a cervical spinal cord injury classified as AIS A, B, or C, with specific motor activity and BMI <40.
Select...
My spinal injury is classified as AIS A, B, or C.
Select...
My upper body strength score is 28 or less.
Select...
My spinal cord injury is between my neck and mid-back, with some arm movement.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Upper Extremity Motor Score (UEMS)
Secondary outcome measures
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
+1 more

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
3,080 Total Patients Enrolled
Mitsubishi Tanabe Pharma Development America, Inc.Lead Sponsor
21 Previous Clinical Trials
2,410 Total Patients Enrolled
Head of Medical ScienceStudy DirectorMitsubishi Tanabe Pharma America Inc.
17 Previous Clinical Trials
2,264 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization to MT-3921?

"The safety of MT-3921 was appraised as a 2, since this is only at the Phase 2 stage; while there are some data affirming its security, none can attest to its efficacy."

Answered by AI

Does this research endeavor have an age limitation for potential participants?

"This clinical trial is seeking participants aged 18 or over, but no older than 75."

Answered by AI

What is the scope of the patient sample for this research?

"This trial requires 72 participants, as defined by its inclusion criteria. The sponsor, Mitsubishi Tanabe Pharma Development America Inc., is running the medical experiment from two locations: Medical College of Wisconsin - Froedtert Hospital in Milwaukee and Stanford University in California."

Answered by AI

How prevalent is this experimental protocol throughout the state?

"Currently, 69 sites are enrolling patients across the United States, from Milwaukee and Stanford to Houston. To reduce travel expenses associated with participating in this clinical trial, it is essential that individuals select a location nearest them."

Answered by AI

Is enrollment currently open for this research trial?

"According to clinicaltrials.gov, this medical inquiry is actively seeking patients who meet the criteria. It was initially posted on August 27th 2021 and last updated November 14th 2022."

Answered by AI

Who is eligible to partake in this medical research?

"This clinical research is open to individuals aged between 18 and 75 who have wounds. 72 participants are anticipated for the duration of this trial."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Ohio
Other
Colorado
How old are they?
18 - 65
65+
What site did they apply to?
University of California - Davis Health
UCHealth Memorial Hospital
University of Miami
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Recent traumatic spinal cord inj. See if my neropherthy could get better. I decided to try to be better and live more with quality of life.
PatientReceived 2+ prior treatments
I think this would be a great opportunity to better my health and help research on spinal cord injuries to progress.
PatientReceived no prior treatments
I'd like to try out the meds they will administer at the trial to see if it will help better my upper body movement and or strength. Id like to help future patients with cervical spinal cord injuries in this form.
PatientReceived 2+ prior treatments
~20 spots leftby Mar 2025