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

Phase 1

Completed

• Conditions: umbar Radiculopathy; sciatica; low back pain; leg pain; Lumbosacral Radiculopathy; radiculopathy; Peripheral nervous system disease; Neuromuscular disease; Nervous system disease; Lumbar Radiculopathy

• Registration Number: ACTRN12619001235190
• Lead Sponsor: SpineThera Australia PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-06
• Study Completion: 2022-06-21
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with a 50% or greater improvement in mean Worst Daily Leg Pain (Responsders) assessed by a standard Numeric Rating Scale (NRS-11) for patient self-reporting of pain.[Baseline to 60 days]