Riluzole Clinical Trial for Spinal Cord Injury in Australia

Release date: 25-Nov-2014

Organisation: The Spinal Cord Injury Network

Sydney is set to join an international multi-centre clinical trial using a neuroprotective drug known as riluzole.

The Phase II clinical trial is led by Dr Michael Fehlings in collaboration with AO Spine North America and the North American Clinical Trials Network (NACTN).

Orthopaedic surgeon Dr Ralph Stanford will lead the clinical trial across three sites; the Prince of Wales Hospital, the Royal North Shore Hospital and Royal Rehab , with Chief Investigators, Dr Jonathon Ball and Dr Gerard Weber.

A fourth site, the Royal Adelaide Hospital, will join the study in due course.

The Spinal Cord Injury Network funded a feasibility study to conduct the trial in Australia and facilitated regular meetings to bring the sites together. Clinical Trials Coordinator Suzanne Ryan was funded by the Network to assist Dr Stanford in the complex preparatory work for the study including gaining ethics and TGA regulatory approval and overseeing manufacture of drug placebo.

Riluzole is a sodium channel blocker commonly used for the treatment of motor neurone disease such as Amyotrophic Lateral Sclerosis (ALS). When used for spinal cord injury, it is believed that riluzole may improve the rate of neurological recovery, reduce inflammation, and protect damaged but viable neural tissue after injury.

The riluzole trial also known as RISCIS (Riluzole in Spinal Cord Injury Study) will require a total of 351 cases worldwide. First treatment dose must be given within the first 12 hours of spinal cord injury and continued for two weeks, with patient follow-up scheduled for 12 months.

Dr Ralph Stanford from the Prince of Wales Hospital in Sydney highlighted the importance of cooperation required for the Phase II trial.

“The RISCIS-riluzole trial will be a complex process requiring the input of many dedicated people, but it is also a great opportunity for Australia to be part of world-class research,” he said.

The Spinal Cord Injury Network is an alliance of leading scientists, healthcare professionals, community members and key stakeholders who are working together to improve treatments and find a cure for spinal cord injury in Australia. Donations are needed to help the Network fund research, advocacy and support.

For more information about the Spinal Cord Injury Network visit spinalnetwork.org.au



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