Riluzole in Spinal Cord Injury Study

Drug

General health

Online since 1 November 2021, updated 898 days ago

About this trial

This trial is recruiting individuals with acute cervical (neck area) spinal cord injuries to test an oral drug called Riluzole, a medication already approved for amyotrophic lateral sclerosis (ALS). Earlier studies suggest Riluzole is safe, may preserve spinal cord nerve tissue, and may improve behavioral outcomes. The trial will investigate whether the drug improves strength, recovery, and quality of life. Participants will receive the drug or placebo within 24 hours of injury for 14 days. Neither investigator nor participant will know who is in the treatment arm; this “masking” ensures unbiased procedures and objective outcomes.

Included participants

Gender

All

Age

18 - 75 years

Injury level

C4 - C8

Severity (AIS)?

AIS-A

AIS-B

AIS-C

Time since injury

≤ 12 hours

Injury type

Traumatic

Healthy volunteers

C4-C8

Additionally, participants must

NOT have had a previous spinal cord injury

NOT have a penatrating injury, e.g. gunshot or stab

What’s involved

Type

Drug

Details

Within 12 hours of the injury, the participant must be at one of the hospital study centers. The participant will be administered Riluzole or placebo orally twice-a-day for 14 days. Outcome assessments will be performed on day 1, 3, 7, Week 2, Month 3, 6 and 12 post-administration.

Potential benefits

Main benefits

General health

Additional benefits

Arm/hand function

Mental health and psychosocial factors

Sensory function

Standing/walking/mobility

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

Wings for Life supports SCITrialsFinder

Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

Learn more

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