A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial.Objective.
To evaluate the efficacy and safety of chemonucleolysis with condoliase in patients with lumbar disc herniation (LDH).Summary of Background Data.
Condoliase is a pure mucopolysaccharidase derived from a bacterium, Proteus vulgaris that has high substrate specificity for chondroitin sulfate and hyaluronic acid in the nucleus pulposus of the intervertebral disc.Methods.
In this study, patients aged 20 to 70 years with unilateral leg pain, positive straight leg raise test, and a contained LDH were recruited in Japan. Patients were treated with a single injection of condoliase (1.25 U) or placebo and were followed for 1 year after administration. The primary endpoint was change in worst leg pain from baseline to week 13. The secondary endpoints included responder rate, and the changes from baseline up to week 52 in the worst leg pain, worst back pain, Oswestry Disability Index, 36-Item Short-Form Health Survey, neurologic examinations, and imaging parameters.Results.
A total of 82 and 81 patients received an injection of condoliase and placebo, respectively. The average changes in worst leg pain from baseline to week 13 (primary endpoint) were −49.5 mm in the condoliase group and −34.3 mm in the placebo group, and the difference of −15.2 mm was significant (95% confidence interval, −24.2 to −6.2; P = 0.001). Significant improvements were observed in the condoliase groups, compared with the placebo group, in most secondary endpoints at 1 year after administration. In the condoliase group, back pain, Modic type 1 change, and decrease in disc height were frequently reported, without any clinically relevant consequences.Conclusion.
Condoliase significantly improved symptoms in patients with LDH and was well tolerated. Condoliase is a novel and potent chemonucleolytic drug for the treatment of LDH.Conclusion.
Level of Evidence: 1