NCT03952377

Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain

A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Phase I/II, First-in-Human Study to Assess the Safety and Efficacy of Two Doses of SX600 Administered by Lumbosacral Transforaminal Epidural Injection in Patients With Radicular Pain Secondary to Lumbar Intervertebral Disc Herniation

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: SpineThera Australia PTY LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II, double-blind, parallel-group, randomized, placebo-controlled multi-centre trial in 180 patients randomized 1:1:1 to receive the IMP (Dexamethasone acetate microspheres for extended-release injectable micro-suspension, SX600 at 12.5 mg or 25.0 mg) or Placebo (0.9% Sodium Chloride for Injection, BP) via transforaminal epidural injection to the lumbosacral epidural space.

Conditions

• Lumbar Radiculopathy

Interventions

Type	Name	Description
DRUG	SX600	Transforaminal Epidural Injection
DRUG	Placebo	Transforaminal Epidural Injection

Timeline

• Start date: 2019-11-04
• Primary completion: 2022-02-21
• Completion: 2022-06-21
• First posted: 2019-05-16
• Last updated: 2024-01-10
• Results posted: 2024-01-10

Locations

10 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study