What is RISCIS?

The North American Clinical Trials Network (NACTN) has partnered with AOSpine North America to conduct a Phase II/III clinical trial called RISCIS. This study will evaluate the safety and effectiveness of the drug riluzole to see if it improves recovery following a spinal cord injury compared to a placebo.

Riluzole is a neuroprotective drug, which means it protects nerve cells after injury or in diseases that cause neurological decline, including loss of sensation and movement.

What do we know about riluzole?

Riluzole aids in preventing cell death and has been studied in neurotrauma and neuro-degenerative diseases. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis (ALS) but is not approved for spinal cord injury.

Riluzole is thought to work by blocking sodium channels, which in turn prevents the stimulation of glutamate receptors. Excess glutamate can be toxic to nerves.

NACTN has already conducted a successful Phase I study of riluzole that evaluated the safety of the drug in 36 patients with acute spinal cord injury. The study demonstrated that the drug is indeed safe and well-tolerated.

Quick facts about RISCIS

  • Many centers around the word are participating in RISCIS, which is a “Randomized, Placebo-Controlled, Double-Blinded Clinical Trial of Efficacy and Safety in Acute Spinal Cord Injury.”
  • 351 people between the ages of 18 and 75 years will be enrolled.
  • They must have sustained a spinal cord injury between C4-C8 and receive riluzole within 12 hours of injury.
  • RISCIS is enrolling subjects with cervical injuries because that is the group that appeared to show the most improvement from riluzole in the Phase I safety study.

For more information, visit www.ClinicalTrials.gov and search for Spinal cord injury AND riluzole or use the identifier NCT01597518.

What is the RISCIS “pharmacology substudy?”

The NACTN centers are also conducting a substudy to learn more about riluzole’s pharmacology (how the body reacts to the study drug) and its pharmacodynamics (the effects of the study drug on the body) in order to determine the best dosage.

This is an extremely important part of RISCIS. In the Phase l study, levels of riluzole in the blood were measured. It was found that although all 36 subjects were given the same dosage of the drug, some had high levels of riluzole in their blood and others low. This may indicate a potential connection between higher blood levels of riluzole and better outcomes.

In the Phase II/III trial, NACTN researchers will continue to monitor this connection in order to establish the ideal blood level for the best outcome. If this level can be established, the oral dosage of riluzole can be adjusted for each person.