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

  • STATUS
    Recruiting
  • End date
    Sep 26, 2022
  • participants needed
    180
  • sponsor
    SpineThera Australia PTY LTD
Updated on 26 July 2021

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.

Details
Condition Lumbar Radiculopathy
Treatment Placebo, SX600
Clinical Study IdentifierNCT03952377
SponsorSpineThera Australia PTY LTD
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

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

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
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