Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Drug

Arm/hand function

Online since 5 November 2021, updated 894 days ago

About this trial

This trial is recruiting individuals with acute cervical (neck area) spinal cord injuries to test the safety and effect of an experimental drug (MT-3921). Earlier studies have shown that the drug may protect nerves, reduce inflammation and promote regeneration. Participants will be randomized to either receive the MT-3921 drug injected into a vein or a placebo (inactive) drug. Final testing (i.e., arm and hand function tests) will be performed 6 months after the start of the intervention.

Included participants

Gender

All

Age

18 - 70 years

Injury level

C4 - C7

Severity (AIS)?

AIS-A

AIS-B

AIS-C

Time since injury

≤ 3 weeks

Injury type

Traumatic

Healthy volunteers

C4-C7

Additionally, participants must

have a body mass index <40

NOT have penetrating spinal cord injury (gunshot or knife wound)

NOT have hereditary fructose intolerance

What’s involved

Type

Drug

Details

The participant will be randomized (2:1) to either receive 1) the MT-3921 drug injected into a vein or 2) a placebo drug. Frequency and total number of injections is not provided. Further information needs to be acquired directly from the investigator.” Final testing (i.e., arm and hand function tests and activities of daily living)) will be performed 6 months after the start of the intervention.

Potential benefits

Main benefits

Arm/hand function

Additional benefits

General health

Sensory function

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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