drugset / Trial / NCT06022263
STA363 in the Treatment of Lumbar Disc Herniation
Phase 1
Completed
25 enrolled
Stayble Therapeutics
Antaros Medical · collabCromsource · collabVIEDOC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactic Acid | Other / unclassified | 180 mg | Other |