Lancet Neurology: Safety and effective treatment of patients with decompressive cervical vertebral decompression surgery: a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial

Defecation spinal cord cervical vertebral disease is the most common form of non-traumatic spinal cord injury and the main cause of spinal cord dysfunction in adults worldwide.
The clinical pathology of the disease is secondary to osteoarthritis degenerative changes (e.g. cervical vertebral disease) or spinal ligament aberrations (e.g. posterior ligament osteopathy) of the cervical vertebral tube access stenosis, accompanied or not accompanied by overlapping congenital stenosis, resulting in chronic spinal cord compression and loss of clinical function.
is an anticonvulsant drug that has been approved by the U.S. Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis.
this trial mainly studies whether liruazole can improve the prognosis of patients with dedefed cervical vertebral decompression surgery.
study was mainly aimed at patients with moderate to severe denative cervical vertebral disease with a score of 8-14 from the Japan Orthopaedic Association (mJOA) between the ages of 18 and 80.
patients were randomly assigned (1:1) to receive oral liruzo (50 mg twice a day, 14 days before surgery, 28 days after surgery) or placebo.
endpoint was the change in mJOA scores from baseline to 6 months in the Intentional Therapy (ITT) population, which was defined as all individuals who received random grouping and surgical decompression.
31 January 2012 to 16 May 2017, 408 patients were screened for this trial.
of the patients screened, 300 were eligible (mITT population), of whom 290 received decompression surgery (ITT population) and liruzo (n=141) or placebo (n=149).
in the six-month follow-up, there was no difference between the Liruzo and placebo groups in terms of the main endpoints of mJOA score changes: 2.45 points (95% CI 2.08-2.82 points) vs 2.83 points (2.47-3.19), difference -0.38 points (0.90-0.13; p-0.14).
the most common adverse reactions in the course of the experiment were pain in the neck, arms or shoulders, abnormal feeling in the arms, difficulty swallowing and worsening of the condition.
43 severe adverse reactions were reported in 33 (22%) of the 147 patients in the liruzo group, and 34 serious adverse reactions were reported in 29 (19%) of the 153 patients in the placebo group.
Fehlings, Michael G et al. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial. The Lancet Neurology, Volume 20, Issue 2, 98 - 106MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Mets Medicine" or "Source: MedSci Originals" are owned by Mets Medical and are not authorized to be reproduced by any media, website or individual.
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