Condoliase is a mucopolysaccharidase, with a high specificity for chondroitin sulfate and hyaluronic acid of the nucleus pulposus. This phase three, randomized, clinical trial was designed to verify the efficacy and safety of condoliase for the treatment of lumbar disc herniation (LDH)．
METHODSSubjects were 163 patients, ranging in age from 20 to 70 years, each with symptomatic LDH. The subjects were randomized to receive either 1 mL of condoliase or a placebo, delivered under fluoroscopy into the nucleus pulposus, and then followed through week 52. The primary endpoint was the reduction in patient-assessed leg pain at week 13, using a 100 mm visual analogue scale (VAS)．
Secondary endpoints included the "responder rate" (defined as at least 50% improvement in worst leg pain), and changes at week 52 on the VAS, the Oswestry Disability Index (ODI), the 36-Point Health Survey Form, neurologic exam results, volume of disc herniation, disc height and the need for lumbar surgery.
RESULTSSignificant reductions in VAS scores were noted in both groups, with mean improvements of 49.5 mm after condoliase and 34.3mm after placebo (P＝0.001). The responder rate was higher in the condoliase group at weeks 13 and 52 (P＝0.008 and P＝0.002, respectively). Also, at week 52, the condoliase group had superior results in the change in disc height and volume, hypesthesia, straight leg test results and the physical component scores on the SF-36.
CONCLUSIONThis study of patients with symptomatic lumbar disc herniation found that chemonucleolytic treatment with condoliase may improve pain and function.