Central Alabama Research | Birmingham, AL
Status and phase
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About
The purpose of the study is to confirm the safety and effectiveness of SB-01 For Injection in adult patients with chronic low back pain and related disability due to Lumbar Degenerative Disc Disease. The primary effectiveness hypothesis is superiority of the investigational product relative to control in terms of the percentage of subjects improving in pain-related disability.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
18 years of age or older
Back pain greater than 'worst leg pain' as measured by the NRS
Diagnosed with one or two contiguous level(s) lumbar (L1-S1) disc degeneration of Pfirrmann Grade 3 and/or 4 determined by MRI analyzed by the independent radiologic central lab
Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
Baseline ODI score ≥ 40/100
Baseline NRS ≥ 4 points (Back)
Willing and able to provide Informed Consent for study participation
Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet
Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):
Patient must verify that:
Exclusion criteria
To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.
Prior epidural, sacroiliac joint, or facet injections at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal)
Prior interventional procedures of other types at any lumbosacral level at any time (e.g., intradiscal injection, basivertebral nerve ablation, biacuplasty; radiofrequency (RF) ablation, spinal cord stimulator, others)
Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
Prior fracture at any lumbar level
Significant neurologic symptoms:
MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab
Lumbar coronal deformity, determined by the independent radiologic central lab:
a. L1-S1 regional deformity > 25 degrees
Spondylolysis at any level
Lumbar inflammatory spondylitis
Recent history (previous six months) of chemical or alcohol dependence
Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
Depression or Somatization defined through the Distress and Risk Assessment Method (DRAM) scoring with Zung score > 33 or Zung > 17 and the Modified Somatic Perception Questionnaire (MSPQ) score > 12
Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec)
Active systemic infection
Infection at the site of procedure pre-operatively
Cauda equina syndrome or neurogenic bowel/bladder dysfunction
Any terminal, systemic, or autoimmune disease including fibromyalgia, which may, in the opinion of the Principal Investigator compromise a subject's ability to comply with study procedures, and/or confound data
Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)
Any disease, condition or surgery which might impair healing, such as:
Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
Currently a prisoner
Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
Patient cannot be currently using the prohibited medications listed in the protocol
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups, including a placebo group
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Central trial contact
Pamela Zicker, NP
Data sourced from clinicaltrials.gov
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