SI-6603 (Condoliase) Study for Lumbar Disc Herniation

Description

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

Lumbar Disc Herniation Radiculopathy Sciatica Intradiscal injection Chemonucleolysis Hernia

Open to people ages 30-70

Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies.
Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 35 days prior to randomization.
Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 10 days prior to randomization.
Subjects who have taken extended- or controlled-release opioids within the past 6 months, subjects who average more than 2 doses per week of immediate-release opioids, or subjects who use cannabis for relief of pain
Subjects with a body mass index (BMI) ≥35.
Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.

University of California San Diego - Center for Pain Medicine accepting new patients
La Jolla California 92093 United States
The Helm Center for Pain Management accepting new patients
Laguna Woods California 92637 United States