A prospective, randomised, double-blinded, placebo-controlled study investigating the safety and tolerability in patients with radiculopathy caused by lumbar disc herniation.

Phase 1

• Conditions: Radiculopathy due to lumbar intervertebral disc herniation; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: PTClassification code 10050219Term: Lumbar radiculopathySystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.0Level: HLTClassification code 10052772Term: Lumbar spinal cord and nerve root disordersSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-006503-15-PL
• Lead Sponsor: Stayble Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-06
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified