MT-3921 for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+73 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mitsubishi Tanabe Pharma America Inc.

Prior Safety Data

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.

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

My spinal injury is classified as AIS A, B, or C.

My upper body strength score is 28 or less.

My spinal cord injury is between my neck and mid-back, with some arm movement.

Exclusion Criteria

I have hereditary fructose intolerance.

My spinal cord is completely severed.

I have a penetrating injury to my spinal cord.

I am currently pregnant or breastfeeding.

I have had a severe injury with an ISS score over 25.

I currently have COVID-19.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MT-3921Experimental Treatment1 Intervention

Intravenous (IV)

Group II: PlaceboPlacebo Group1 Intervention

Intravenous (IV)