MT-3921 for Spinal Cord Injury

Recruiting at 73 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

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Head of Medical Science

Principal Investigator

Mitsubishi Tanabe Pharma America Inc.

Eligibility Criteria

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.

My spinal cord is completely severed.

Timeline

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

Treatment Details

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.

Participant Groups

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+