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

SpineThera

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Lumbar Radiculopathy

Treatments: Drug: Placebo; Drug: SX600

Study type: Interventional

Funder types: Industry

Identifiers

NCT03952377

CLIN-0012-STA19-01

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

0.9% Sodium Chloride for Injection

Placebo Comparator group

Treatment:

Drug: Placebo

12.5 mg SX600

Experimental group

Description:

Low Dose

Treatment:

Drug: SX600

25.0 mg SX600

Experimental group

Description:

High Dose

Treatment:

Drug: SX600