Radiculopathy due to lumbar intervertebral disc herniation MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10050219 Term: Lumbar radiculopathy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: HLT Classification code 10052772 Term: Lumbar spinal cord and nerve root disorders System Organ Class: 10029205 - Nervo
Conditions
Interventions
Product Name: STA363
Product Code: STA363
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
CAS Number: 79-33-4
Current Sponsor code: (S)-Lactic acid
Other descriptive nam
Sponsors
Stayble Therapeutics
Eligibility
Sex/Gender
All
Inclusion 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 the impaired nerve root 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: a. Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days b. NRS daily pain scores between 3-9 c. Not more than 2 NRS scores of «3» Note! Patients must be blinded to the above described NRS inclusion criteria 11b and 11c. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate safety and tolerability after injection of STA363 into a herniated lumbar disc (primary completion time 6 months).;Secondary Objective: • To evaluate the effect of STA363 on disc volume measured by magnetic resonance imaging (MRI) as compared to placebo • To evaluate the effects of STA363 on disc height measured by MRI as compared to placebo • To evaluate the effects of STA363 on intensity of the nucleus pulposus measured by MRI as compared to placebo at T2-weighted MRI • To evaluate the effects of STA363 on radicular leg pain as compared to placebo • To evaluate the effects of STA363 on Patient Global Impression of Change (PGIC) as compared to placebo subject's compliance to treatment;Primary end point(s): • Incidence and nature of adverse events • Changes in physical examination findings • Changes in vital signs (blood pressure and heart rate) • Changes in 12-lead electrocardiogram (ECG) • Changes in laboratory tests (haematology, clinical chemistry); results outside the normal range considered clinically significant will be documented as adverse events (AEs) • Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale [NRS]) • Other changes in disc morphology (e.g., Modic changes, high-intensity zone), as well as other radiology findings) (T2-weighted MRI);Timepoint(s) of evaluation of this end point: Baseline, Day 1, Month 1, Month 3, Month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from baseline to visit 4-6 in volume of the disc as measured by MRI • Change from baseline to visit 4-6 in height of the disc as measured by MRI • Change from baseline to visit 4-6 in intensity of the NP as measured by MRI • Change from baseline to visit 3-6 in average daily radicular leg pain as measured by NRS for 7 days • Change from baseline to visit 3-6 in PGIC;Timepoint(s) of evaluation of this end point: Baseline, Week 1, Month 1, Month 3, Month 6. | — |
Countries
Poland
Contacts
Public ContactProject Manager
Stayble Therapeutics
Outcome results
None listed