Treatment of lumbar disc herniation with STA363

A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation

This study is testing an injectable treatment called STA363 to see if it can help people with sciatica from a herniated disc feel better and reduce their pain.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Stayble Therapeutics (Industry-sponsored)
• Locations: 1 site (Lublin, Lubelskie)
• Trial ID: NCT06022263 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and tolerability of STA363, an injectable treatment, for patients suffering from sciatica due to lumbar disc herniation. A total of 24 participants will be recruited and randomized to receive either STA363 or a placebo injection into the herniated disc, guided by fluoroscopy. The study will assess changes in disc volume, herniation size, and symptom relief over a follow-up period of six months, with data collected through MRI and daily pain intensity recordings. The primary focus is on safety and tolerability, while secondary objectives include evaluating the effectiveness of the treatment in reducing pain and disc herniation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 50 with a confirmed diagnosis of unilateral radiculopathy due to a single lumbar disc herniation.

Not a fit: Patients with multiple disc herniations or those who have not experienced sufficient relief from conservative therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from sciatica symptoms and improve the quality of life for patients with lumbar disc herniation.

How similar studies have performed: While this approach is novel, similar studies have shown promise in using injectable treatments for disc herniation, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent prior to any study-related procedures
2. Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI
3. Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5)
4. Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
5. The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
6. Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies
7. Ability to understand the written and verbal information about the study
8. Male and female patients 18 years or older but 50 years or younger
9. Women of childbearing potential eligible if using effective contraceptives
10. Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2
11. Patients who meet all the following NRS selection criteria for radicular leg pain:

    1. Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
    2. NRS daily pain scores between 3-9
    3. Not more than 2 NRS scores of "3"

Exclusion criteria:

1. Treatment with any investigational product within 3 months prior to the screening visit
2. Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
3. Patient has a bulging disc
4. Patient has experienced symptoms of lumbar disc herniation for more than 6 months
5. Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed)
6. Patient has cauda equina syndrome
7. Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
8. Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy
9. Untreated, ongoing active infection and/or discitis
10. Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
11. Evidence of prior lumbar vertebral body fracture or trauma.
12. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s).
13. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
14. Patients previously included in the study.
15. Patients suffering from psychosomatic pain in the opinion of the Investigator.
16. Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
17. Known alcohol and/or drug abuse.
18. Pregnant or lactating females, or intention to become pregnant within the study period.
19. Known allergy or intolerance to the contrast agent Omnipaque®.
20. Known opioid allergy or intolerance.
21. Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study.
22. Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.

Where this trial is running

Lublin, Lubelskie

• Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji — Lublin, Lubelskie, Poland (Recruiting)

Study contacts

• Study coordinator: Tomasz Blicharski, MD, PhD

Conditions Lumbar Disc Herniation; Lumbar radiculopathy