NISCI - Nogo Inhibition in Spinal Cord Injury

Drug

Arm/hand function

Online since 6 September 2022, updated 821 days ago

About this trial

This trial is enrolling individuals with acute cervical (neck area) spinal cord injuries to assess an experimental drug (NG-101). In earlier studies, NG-101 appeared to neutralize a molecule in the spinal cord that blocks nerve growth. The research team wants to see if the drug promotes nerve regeneration. If selected for the study, participants must begin the series of drug injections within 4 to 28 days following SCI. Each will be randomly assigned to one of two study groups: 1) receiving six injections of NG-101 over 30 days, or 2) receiving six injections of a placebo over 30 days. This study hopes to build on evidence from a smaller preliminary trial that demonstrated reasonable safety and tolerability of this drug.

Included participants

Gender

All

Age

18 - 70 years

Injury level

C1 - C8

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

4 days - 28 days

Injury type

Traumatic

Healthy volunteers

C1-C8

Additionally, participants must

NOT have penetrating injury, e.g. gunshot or knife wound

What’s involved

Type

Drug

Details

- The participant will be randomly assigned to one of the two study groups: 1) Those receiving six injections of NG-101 over 30 days, or 2) those receiving six injections of a placebo over 30 days. - Over a period of 24 weeks: physical examinations, functional activity testing, testing of how nerves are functioning using nerve stimulation techniques, and measurements of drug concentrations in the spinal fluid obtained by spinal tap

Potential benefits

Main benefits

Arm/hand function

Additional benefits

Bladder health/function

General health

Mental health and psychosocial factors

Standing/walking/mobility

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

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