Spinal Network Clinical Trials
Our mission at Spinal Network is to unite the spinal cord injury community to optimise the quality of life and maximise recovery for those with a spinal cord injury.
The Spinal Network is proud to collaborate with peak organisations in the field to bring together the best minds and push forward the boundaries of spinal cord injury research and clinical trials.
In doing so, we are currently supporting three major clinical trials in Australia: Riluzole in Spinal Cord Injury Study (RISCIS), Immediate Cooling and Early Decompression (ICED), Minocycline in Acute Spinal Cord Injury (MASC), and Intravenous Immunoglobulum (IVIg).
Riluzole in Spinal Cord Injury Study (RISCIS)
RISCIS is a collaborative, multi-centre, randomised, placebo-controlled, double-blinded trial of efficacy and safety of Riluzole in Acute Spinal Cord Injury. The purpose of this study is to evaluate efficacy and safety of Riluzole in the treatment of patients with acute cervical spinal cord injury. The study drug Riluzole aids in preventing cell death and has been approved for the treatment of amyotrophic lateral sclerosis (ALS).
The Phase II clinical trial is led by Dr Michael Fehlings (Toronto) in collaboration with AO Spine North America and the North American Clinical Trials Network (NACTN) in the United States.
Australian orthopaedic surgeon Dr Ralph Stanford is the Lead Principal Investigator at the Prince of Wales Hospital NSW, with Site Principal Investigators being Dr Jonathon Ball at Royal North Shore Hospital NSW, Dr Gerard Weber at Royal Rehab NSW and Professor Brian Freeman at Royal Adelaide Hospital SA.
The Spinal 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.
Immediate Cooling and Early Decompression (ICED)
The aim of the ICED study is to determine whether the combination of hypothermia and early decompression is able to improve outcomes in patients with severe cervical spinal cord injuries.
Research on animals has shown greatly improved outcomes if decompressive surgery is performed in the first hours after a spinal cord injury. However, urgent decompression within a few hours in humans is difficult because of the time occupied by transportation, investigation, and stabilisation of the patient as well as the organisation of surgery. Hypothermia can potentially buy time to perform decompressive surgery within a clinically acceptable timeframe.
The Spinal Network provided seed funding support for Dr Peter Batchelor to conduct preliminary work to develop the study for a large clinical trial.
Please click here for more information about the ICED study.
Minocycline in Acute Spinal Cord Injury (MASC)
The MASC trial is sponsored by the Rick Hansen Institute and has sites at Canada’s University of Calgary and Queensland’s Princess Alexandra Hospital.The objective of the MASC study is to assess the efficacy of IV minocycline in improving neurological and functional outcome after acute non-penetrating traumatic spinal cord injury. ClinicalTrials.gov Identifier: NCT01828203.
Please click here for more information about MASC.
Intravenous Immunoglobulin Therapy for Spinal Cord Injury (IVIgSCI)
The principal investigator is Dr Marc Ruitenberg, School of Biomedical Sciences, Faculty of Medicine, The University of Queensland. The extensive pre-clinical studies had indicated that intravenous immunoglobulin (IVIg) therapy was highly beneficial and significantly improved the neurological recovery if administered during the acute phase of spinal cord injury. As IVIg was already in clinical use as an immunomodulatory treatment for a variety of other disorders (incl. neurological conditions) and had a good safety profile, it was now wished to explore the feasibility of treating human patients that had suffered either a cervical or thoracic spinal cord injury with IVIg. Australian New Zealand Clinical Trials Registry trial ID ACTRN12616001385437
Please click here for press release.