STA363 in the Treatment of Lumbar Disc Herniation (NCT06022263) | Clinical Trial Compass
CompletedPhase 1
STA363 in the Treatment of Lumbar Disc Herniation
Poland25 participantsStarted 2023-07-25
Plain-language summary
The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are:
1. Is the treatment safe and tolerable?
2. Does the volume of the disc and the herniation decrease?
3. Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose).
Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.
Who can participate
Age range18 Years ā 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Signed informed consent prior to any study-related procedures
ā. 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
ā. Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5)
ā. Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
ā. The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
ā. 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
ā. Ability to understand the written and verbal information about the study
ā. Male and female patients 18 years or older but 50 years or younger
Exclusion criteria
What they're measuring
1
Safety and tolerability
Timeframe: Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)
. Treatment with any investigational product within 3 months prior to the screening visit
ā. Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
ā. Patient has a bulging disc
ā. Patient has experienced symptoms of lumbar disc herniation for more than 6 months
ā. Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed)
ā. Patient has cauda equina syndrome
ā. Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
ā. 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