Sciatica Study

Sciatica (with or without Low Back Pain)

This trial is for those patients who suffer from Sciatica and low back pain. Sciatica is a shooting and deep-seated pain in the leg resulting from disc herniation either at L4-5 or at L5-S1 levels compressing a nerve root.
A Multicenter, Randomized, Double-blind, Sham-controlled Comparative Study of SI 6603, also known as Condoliase (the Investigational Product) in Subjects with Lumbar Disk herniation (phase 3).
The primary objective is to evaluate the effectiveness of a single dose intervertebral disk injection of the investigational product compared to control in subjects with lumbar disk herniation by comparing the changes in worse leg pain during the past 24 hours as assessed by visual analog scale from baseline to Week 13 after injection of the investigational product.

Selected Inclusion Criteria

Please call for full evaluation of you fulfil the following selection criteria:● If you suffer from severe one-sided leg pain with or without back pain and have been diagnosed to have sciatica, you may qualify for the study.● A diagnosis of contained disc herniation at L4-5 or L5-S1.● If you are having difficulty in straightening your leg because of shooting leg pain.● If the pain is in the same leg as the herniated disc at L4-5 or L5-S1 levels.● If the symptoms were present for at least six weeks and maximum for 12 months or less.● The patient has to have the symptoms at the time of participation.● Participants must have failed six weeks of conservative treatment, such as PT, Chiropractic treatment, Epidural steroid injections, etc.
If you meet all or some of these criteria please call us immediately. Don't be in pain. Please explore the new investigational therapeutic option.
Please review the excerpts of the publiseh phase 2 of the study in the Journal of Neurosurgery Spine, Feb 9, 2018.

Results

A total of 194 patients received an injection of Condoliase or placebo. They concluded that the investigational product significantly improved clinical symptoms in the patient with lumbar disk herniation and was well tolerated. The incidence of adverse drug reaction and decrease in disk height are dose-dependent and thereby suggesting that 1.25U (the dose that is considered for the study) would be the recommended clinical dose of condoliase. The decrease in the worst leg pain in all 3 Condoliase groups was observed from week 1 through week 52. The worst back pain and results of the straight leg raise test showed a tendency for sustained improvement in each of the treatment groups until week 52. No patient died or developed anaphylaxis or neurological sequelae.