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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Drug: SX600
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0.9% Sodium Chloride for Injection<br> | Drug: Placebo<br>* Transforaminal Epidural Injection<br>|
| Experimental: 12.5 mg SX600<br>Low Dose | Drug: SX600<br>* Transforaminal Epidural Injection<br>|
| Experimental: 25.0 mg SX600<br>High Dose | Drug: SX600<br>* Transforaminal Epidural Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a 50% or greater improvement in mean Worst Daily Leg Pain (Responders). |  | Baseline to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in functional outcomes as measured by Patient's Global Impression of Change |  | Baseline, 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 | 
| Change from baseline in Short Form 36 Questionnaire (SF-36) | SF-36 is a self-administered, generic health status questionnaire consisting of 36 questions that measure 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The total score will be reported and the range of possible total scores is 0 to 100. A high score defines a more favorable health state. | 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 | 
| Proportion of subjects who reduce dose of concomitant analgesics from baseline, as reported in patient diary |  | Baseline to 14, 30, 60, 90, 120, 150, and 180 days | 
| Proportion of subjects who reduce utilization of supportive health services from baseline, as reported in patient diary |  | 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) |  | 30, 60, 90, 120, 150, and 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain