drugset / Trial / NCT06022263

STA363 in the Treatment of Lumbar Disc Herniation

NCT06022263

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-07-25
Primary completion
2024-09-01
Completion
2024-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactic Acid Other / unclassified 180 mg Other

Indications