CompletedPhase 2ACTRN12619001235190

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

Sponsor

SpineThera Australia PTY LTD

Enrollment

120 participants

Start Date

Nov 19, 2019

Study Type

Interventional

Conditions

Nervous system disease Lumbosacral Radiculopathy Lumbar Radiculopathy Peripheral nervous system disease Neuromuscular disease radiculopathy

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria4

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 Criteria13

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

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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 - Experimen

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

Locations(1)

NSW,QLD,SA,WA,VIC, Australia

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