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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Drug: Placebo; Drug: SX600

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Research Site 03
  • Adelaide, Australia
    • Research Site 12
  • Blacktown, Australia
    • Research Site 10
  • Frankston, Australia
    • Research Site 06
  • Newcastle, Australia
    • Research Site 05
  • Sydney, Australia
    • Research Site 02
  • Sydney, Australia
    • Research Site 04
  • Sydney, Australia
    • Research Site 09
  • Sydney, Australia
    • Research Site 11
  • Townsville, Australia
    • Research Site 08

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main 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 ≥5.0 and ≤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

Main 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 at L4-L5 or L5-S1 or of clinically significant spinal stenosis, or spondylolisthesis (Grade 2 or higher). (Note, asymptomatic foraminal stenosis at other spinal levels is not excluded).
• Has Diabetes Mellitus (Type 1 or Type 2)- prior confirmed HbA1c or OGTT
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0.9% Sodium Chloride for Injection	Drug: Placebo; Transforaminal Epidural Injection
Experimental: 12.5 mg SX600; Low Dose	Drug: SX600; Transforaminal Epidural Injection
Experimental: 25.0 mg SX600; High Dose	Drug: SX600; Transforaminal Epidural Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).	Baseline to 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)		Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by Patient's Global Impression of Change	Very much improved, or much improved from baseline	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by the Oswestry Disability Index	0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Change From Baseline in Short Form 36 Questionnaire (SF-36)	SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported.	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)		Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary		Baseline through 180 days
Time to Loss of Response in the Subset of Patients Who Are Responders at Day 14 (50% or Greater Improvement in Mean Worst Daily Leg Pain)		Day 14 through 180 days

Other Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary	From baseline through 180 days

Collaborators and Investigators

• Sponsor: SpineThera Australia PTY LTD
• Investigators: Principal Investigator: Willem Volschenk, Genesis Research Services

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sciatica; Low Back Pain; Leg Pain; Lumbosacral Radiculopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: CLIN-0012-STA19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes