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SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Sponsor:

Information provided by (Responsible Party):

Seikagaku Corporation

Brief Summary:

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

Criteria

Inclusion Criteria:
  • 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.
Exclusion Criteria:
  • 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 at the affected level of lumbar spine.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 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 7 days prior to randomization.
  • Subjects with a body mass index (BMI) ≥40.
  • Subjects who are receiving compensation according to the Workers’ Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.

Locations

  • Coastal Pain and Spinal Diagnostics, Carlsbad, California, United States, 92009
  • Pain Medicine Associates, Inc., Fountain Valley, California, United States, 92708
  • University of California San Diego – Center for Pain Medicine, La Jolla, California, United States, 92093
  • The Helm Center for Pain Management, Laguna Woods, California, United States, 92637
  • VA Greater Los Angeles Healthcare System, Los Angeles, California, United States, 90073
  • Samaritan Center for Medical Research, Los Gatos, California, United States, 95032
  • Neurovations Research, Napa, California, United States, 94558
  • UC Davis Spine Center, Sacramento, California, United States, 95816
  • St. Mary’s Medical Center, San Francisco, California, United States, 94117
  • Source Healthcare, Santa Monica, California, United States, 90403
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