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

SpineThera Australia PTY LTD10 sites in 1 country56 target enrollmentNovember 4, 2019

ConditionsLumbar Radiculopathy

InterventionsPlacebo SX600

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Lumbar Radiculopathy
Sponsor: SpineThera Australia PTY LTD
Enrollment: 56
Locations: 10
Primary Endpoint: The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 4, 2019

End Date

June 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

SpineThera Australia PTY LTD

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

0.9% Sodium Chloride for Injection

Intervention: Placebo

12.5 mg SX600

Low Dose

Intervention: SX600

25.0 mg SX600

High Dose

Intervention: SX600

Outcomes

Primary Outcomes

The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).

Time Frame: Baseline to 60 days

Secondary Outcomes

Change in Functional Outcomes as Measured by Patient's Global Impression of Change(Baseline, 14, 30, 60, 90, 120, 150, and 180 days)
Change From Baseline in Short Form 36 Questionnaire (SF-36)(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)
Change in Functional Outcomes as Measured by the Oswestry Disability Index(Baseline, 14, 30, 60, 90, 120, 150, and 180 days)
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)
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)
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary(Baseline through 180 days)