MT-3921 for Spinal Cord Injury

No longer recruiting at 78 trial locations

Overseen By Clinical Trials Information Desk, to prevent miscommunication,

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mitsubishi Tanabe Pharma America Inc.

Disqualifiers: Poly-traumatic injury, Malignancy, COVID-19, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called MT-3921 for individuals who have recently experienced a severe cervical spinal cord injury in the neck area. Researchers seek to determine if MT-3921, administered through an IV, can improve recovery compared to a placebo (a substance with no active treatment). Suitable candidates have a neck injury between the C4 and C7 vertebrae and experience significant movement and strength issues. Participants will be randomly assigned to receive either the treatment or a placebo for six months.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in spinal cord injury recovery.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that MT-3921 is likely to be safe for humans?

Research has shown that MT-3921 is being tested for safety in people with spinal cord injuries. So far, it appears generally well-tolerated, with no major safety concerns reported. Some minor side effects have been observed, but they are typical and not serious.

The treatment remains in the clinical trial phase, where researchers carefully study it to ensure safety. This study helps them understand how the treatment affects humans and identify any potential risks. Although MT-3921 is not yet approved by the FDA, it has received Fast Track Designation due to its potential benefits.

Overall, early results are promising, but the treatment continues to be investigated to ensure safety for everyone. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for spinal cord injury, which often includes surgery, rehabilitation, and medications to manage symptoms, MT-3921 is unique because it is administered intravenously and specifically targets the underlying injury mechanisms. Researchers are excited about MT-3921 because it may enhance nerve regeneration and improve motor function recovery by modulating the body's response to the injury, something current treatments don't directly address. This innovative approach could potentially offer new hope for individuals with spinal cord injuries, providing more substantial and direct benefits in nerve healing and functional recovery.

What evidence suggests that MT-3921 might be an effective treatment for spinal cord injury?

Research has shown that MT-3921, which participants in this trial may receive, could help treat spinal cord injuries. Studies suggest that MT-3921 might improve sensation and movement, often impaired by these injuries. Patients using MT-3921 have demonstrated progress in performing daily tasks and gaining independence. The treatment has also received FDA Fast Track status, indicating its importance and urgency for treating spinal cord injuries. While further research is needed, these findings suggest MT-3921 could be a beneficial option for individuals with this condition. ^{1 2 3 5 6}

Who Is on the Research Team?

Head of Medical Science

Principal Investigator

Mitsubishi Tanabe Pharma America Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provide written informed consent prior to beginning any study procedures

I have a cervical spinal cord injury classified as AIS A, B, or C, with specific motor activity and BMI <40.

I have a cervical spinal cord injury.

Exclusion Criteria

I do not have any injuries that would affect my participation in the study's required tests.

I have hereditary fructose intolerance.

You have a problem with using drugs that affect your mind.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravenous (IV) infusions of MT-3921 or placebo in a double-blind manner

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MT-3921
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: MT-3921 Experimental Treatment 1 Intervention

Intravenous (IV)

Group II: Placebo Placebo Group 1 Intervention

Intravenous (IV)

Who Is Running the Clinical Trial?

Mitsubishi Tanabe Pharma America Inc.

Lead Sponsor

Trials

27

Recruited

3,300+

Mitsubishi Tanabe Pharma Development America, Inc.

Lead Sponsor

Trials

22

Recruited

2,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04683848

Study to Assess the Efficacy and Safety of MT-3921 in ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04096950

Safety and Pharmacokinetics Study of MT-3921 in Spinal ... The purpose of this study is to assess the safety, tolerability and pharmacokinetics of MT-3921 in subjects with spinal cord injury.

3. mayo.edu mayo.edu/research/clinical-trials/cls-20520086

A Study to Assess the Effectiveness and Safety of MT-3921 ... The study assesses the effect of MT-3921 on sensory and motor impairment, prehension impairment, and functional outcomes and independence in activities of daily ...

4. mt-pharma.co.jp mt-pharma.co.jp/e/news/assets/pdf/e_MTPC210804_2.pdf

MT-3921 Granted FDA Fast Track Designation for ... (MTDA) received Fast Track Designation for MT-3921 from the U.S. Food and Drug Administration (FDA) for the treatment of spinal cord injury.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12040541/

Lessons Learned and Recommendations from a SCOPE ... They propose a randomized (1:1) double-blinded Phase IIb trial examining placebo versus ibudilast conducted in the European Multicenter Study about Spinal Cord ...

6. studypages.com studypages.com/s/a-study-of-the-safety-and-drug-activity-of-experimental-mt-3921-for-spinal-cord-injury-945754/

A Study of the Safety and Drug Activity of Experimental MT ... The Study Drug MT-3921 has not yet been approved by the FDA. This is a research study to test an experimental drug. This Study in patients with acute spinal ...