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Moderate - Severe Degenerative Disc Disease Evaluation of the Lumbar Spine (MODEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05516992
Recruitment Status : Recruiting
First Posted : August 26, 2022
Last Update Posted : April 2, 2024
Sponsor:
Collaborator:
MCRA
Information provided by (Responsible Party):
Spine BioPharma, Inc

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Drug: SB-01 For Injection Drug: Sham Needle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind, placebo-controlled study.
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled Study, to Evaluate the Safety and Efficacy of SB-01 For Injection for the Treatment of Lumbar Degenerative Disc Disease
Actual Study Start Date : August 19, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : June 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: SB-01 For Injection
Subjects receive a SB-01 For Injection intradiscal injection per treated disc.
 Drug: SB-01 For Injection
Intradiscal injection
Placebo Comparator: Sham Needle
Subjects receive a sham needle placement for each treated disc.
 Drug: Sham Needle
Sham needle placement


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in function on the Oswestry Disability Index (ODI) at 6 months. [ Time Frame: Baseline/Screening and 6 Month ]
    The ODI is a validated, 10-item self-reported instrument assessment of pain-related disability. Possible scores range from 0 (no disability) - 50 (severe disability). Further calculations are applied to reach a percentage score.


Secondary Outcome Measures :
  1. Change from Baseline in pain on the Numerical Rating Scale (NRS) at 6 months. This outcome will only be tested if the primary endpoint is met. [ Time Frame: Baseline/Screening and 6 Month ]
    The NRS is an 11-point scale, self-reported instrument assessment of pain intensity ranging across a continuum from no pain to an extreme amount of pain. The NRS will be collected for: Back and both legs. A lower score indicates less pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Back pain greater than 'worst leg pain' as measured by the NRS
  3. 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
  4. Have chronic low back pain and related disability for at least 6 months with at least 3 months of prior conservative treatment
  5. Baseline ODI score ≥ 40/100
  6. Baseline NRS ≥ 4 points (Back)
  7. Willing and able to provide Informed Consent for study participation
  8. Willing and able to comply with this protocol and be available for the entire duration of the study, including ability to access the internet

  9. Must practice effective contraception during the first 3 months of follow-up (female of childbearing potential and male subjects):

    1. Abstinence or,
    2. Surgical Sterilization or,
    3. Oral Contraceptives or,
    4. Barrier Methods (Condoms, IUD's).

  10. Patient must verify that:

    1. In the case of females, the patient is post-menopausal or is surgically sterile or,
    2. In the case of males, the patient is surgically sterile or,
    3. The patient (male or female) confirms that they are at a point in their life where they are beyond consideration of having children.

Exclusion Criteria:

To qualify for enrollment in this study, patients must meet none of the exclusion criteria as follows.

  1. Prior epidural, sacroiliac joint, or facet injections at any lumbosacral level within the past 4 weeks (e.g., transforaminal, interlaminar, caudal)
  2. 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)
  3. Prior spine surgery at any lumbosacral level at any time (e.g., discectomy, decompression, instrumentation, fusion, fracture treatment, others)
  4. Prior fracture at any lumbar level

  5. Significant neurologic symptoms:

    1. Grade 3/5 or lower strength in any lumbar myotome
    2. Sensory deficit in a clearly radicular or sensory dermatome
  6. MRI evidence of disc height loss > 2/3 of adjacent disc at any level to be injected, determined by the independent radiologic central lab
  7. MRI evidence of other disc degeneration: Pfirrmann Grade 3-5 at any level not to be injected, determined by the independent radiologic central lab
  8. MRI evidence of disc herniation with neural compression at any level, determined by the independent radiologic central lab
  9. MRI evidence of significant stenosis of the central canal at any level, determined by the independent radiologic central lab
  10. MRI evidence of foraminal stenosis with neural compression at any level, determined by the independent radiologic central lab
  11. MRI evidence of moderate-to-severe facet arthrosis with edema at any level, determined by the independent radiologic central lab
  12. Spondylolisthesis (antero or retrolisthesis) > 25% at any level, determined by the independent radiologic central lab

  13. Lumbar coronal deformity, determined by the independent radiologic central lab:

    a. L1-S1 regional deformity > 25 degrees

  14. Spondylolysis at any level
  15. Lumbar inflammatory spondylitis
  16. Recent history (previous six months) of chemical or alcohol dependence
  17. Chronic narcotic use for more than defined as a daily dose of greater than 40 Morphine Equivalent Units (MEUs)
  18. 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
  19. Extreme obesity, defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
  20. A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (msec)
  21. Active systemic infection
  22. Infection at the site of procedure pre-operatively
  23. Cauda equina syndrome or neurogenic bowel/bladder dysfunction
  24. 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
  25. Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease)

  26. Any disease, condition or surgery which might impair healing, such as:

    1. Active malignancy
    2. History of metastatic malignancy
  27. 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
  28. Any planned surgical procedure within the subject participation period (screening through the 12 Month Visit)
  29. Any clinically relevant laboratory result on the screening visit Chem-12, hematology, or coagulation panels
  30. Pregnancy at the time of screening, randomization, or planning to become pregnant during the first 3 months of follow-up
  31. Currently a prisoner
  32. Participation in any other investigational drug, biologic, or medical device study within the last 6 months prior to study procedure
  33. Receiving Work Compensation benefits or engaged in personal spinal injury medical/legal litigation
  34. Patient cannot be currently using the prohibited medications listed in the protocol
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05516992


Contacts
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Contact: Pamela Zicker, NP 831-239-4115 pzicker@spinebiopharma.com

Locations
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Sponsors and Collaborators
Spine BioPharma, Inc
MCRA
Investigators
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Principal Investigator: Christopher Gilligan, MD, MBA Brigham and Women's Spine Center
More Information
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Responsible Party: Spine BioPharma, Inc
ClinicalTrials.gov Identifier: NCT05516992    
Other Study ID Numbers: SB01-M001
First Posted: August 26, 2022    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases