Clinical trial NCT03952377: Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lumbar Radiculopathy
Keywords: Sciatica
Low Back Pain
Lumbosacral Radiculopathy
Leg Pain
Lead sponsor: SpineThera Australia PTY LTD
Sponsor class: INDUSTRY
First posted: 2019-05-16
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
timeFrame: Baseline to 60 days
Secondary outcomes:
measure: The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
timeFrame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
measure: Change in Functional Outcomes as Measured by Patient's Global Impression of Change
timeFrame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
measure: Change in Functional Outcomes as Measured by the Oswestry Disability Index
timeFrame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
measure: Change From Baseline in Short Form 36 Questionnaire (SF-36)
timeFrame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
measure: The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
timeFrame: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
measure: Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
timeFrame: Baseline through 180 days
measure: 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)
timeFrame: Day 14 through 180 days
Other outcomes:
measure: Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary
timeFrame: From baseline through 180 days
Locations:
city: Adelaide
country: Australia
facility: Research Site 03
city: Adelaide
country: Australia
facility: Research Site 12
city: Blacktown
country: Australia
facility: Research Site 10
city: Frankston
country: Australia
facility: Research Site 06
city: Newcastle
country: Australia
facility: Research Site 05
city: Sydney
country: Australia
facility: Research Site 02
city: Sydney
country: Australia
facility: Research Site 04
city: Sydney
country: Australia
facility: Research Site 09
city: Sydney
country: Australia
facility: Research Site 11
city: Townsville
country: Australia
facility: Research Site 08
Study officials:
affiliation: Genesis Research Services
name: Willem Volschenk
role: PRINCIPAL_INVESTIGATOR
References: