NCT06022263

STA363 in the Treatment of Lumbar Disc Herniation

A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Stayble Therapeutics · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will include 24 patients, recruited at 4 different sites, suffering from radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms, disease history and magnetic resonance imaging (MRI) evidence of LDH. Baseline data (e.g. pain recording and MRI data) will be collected, and 1/3 of the patients will then be randomized to intradiscal injection with placebo (Omnipaque with water for injection, 1.5 mL) and 2/3 of the patients will be randomized to STA363 (lactic acid, 120 mg/mL with Omnipaque, 1.5 mL). The injections will be done using fluoroscopic guidance, and the patients will be treated with intravenous antibiotics and sedatives. The first follow-up will be done by phone 1 week after the treatment, while the other follow-ups will be physical visits at month 1, 3 and 6 at the site. In conjunction with the visits, the patient will record daily pain intensity (Numerical Rating Scale) for 7 days using an eDiary, and MRI will be performed. The primary completion time is 6 months with the primary objectives safety and tolerability. Important secondary objectives will be changes of disc volume and pain.

Conditions

• Lumbar Disc Herniation

Interventions

Type	Name	Description
DRUG	Lactic Acid	180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc
DRUG	Placebo	1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc

Timeline

• Start date: 2023-07-25
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2023-09-01
• Last updated: 2025-12-10

Locations

1 site across 1 country: Poland