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

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

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001235190

Acronym

SALIENT

Enrollment

Registered

2019-09-06

Start date

2019-11-19

Completion date

2021-12-07

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Three groups: Treatment: Drugs - SX600 low dose and high dose Treatment: Drugs - Placebo Single administration, once only Placebo Comparator: 0.9% Sodium Chloride for Injection - Experimental: 12.5 mg SX600 - Low Dose Experimental: 25.0 mg SX600 - High Dose Treatment: Drugs: SX600 Transforaminal Epidural Injection Treatment: Drugs: Placebo Transforaminal Epidural Injection

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

- Adult aged 18 to 65 years, capable of providing informed consent, capable of complying with the outcome instruments, and meeting the attendance requirements for review as defined in the study - Presenting with a history of radicular pain of duration of 4 weeks to 6 months, having failed conservative therapy. - Mean Worst Daily Leg Pain score of more than 5.0 and less than 9.0 - Women of child-bearing potential must use a medically accepted method of contraception for the duration of the study plus 30 days and register a negative pregnancy test prior to dosing

Exclusion criteria

- Documented history of allergy or intolerance to components of the Investigational Medicinal Product, relevant radiologic contrast media, or local anaesthetics - Is pregnant or lactating - Has been taking corticosteroid medications routinely in the past 6 months or has received an epidural corticosteroid injection within 12 weeks of screening - Has a BMI greater than 40 kg/m2 - Has radiological evidence of clinically significant foraminal stenosis, spinal stenosis, or spondylolisthesis - Has Diabetes Mellitus (Type 1 or Type 2) - Has a history of significant leg pain unrelated to disc herniation that would significantly compromise assessment of back or leg radicular pain - Has had lumbar back surgery - Has received an implantable device for pain management

Outcome results