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

Lumbar Radiculopathy Clinical Trial

— SALIENT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03952377
• Other study ID #: CLIN-0012-STA19-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: November 4, 2019
• Est. completion date: June 21, 2022

Study information

• Verified date: December 2023
• Source: SpineThera Australia PTY LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: June 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Drug:
• SX600
Transforaminal Epidural Injection
• Placebo
Transforaminal Epidural Injection

Locations

Country	Name	City	State
Australia	Research Site 03	Adelaide
Australia	Research Site 12	Adelaide
Australia	Research Site 10	Blacktown
Australia	Research Site 06	Frankston
Australia	Research Site 05	Newcastle
Australia	Research Site 02	Sydney
Australia	Research Site 04	Sydney
Australia	Research Site 09	Sydney
Australia	Research Site 11	Sydney
Australia	Research Site 08	Townsville

Sponsors (1)

Lead Sponsor	Collaborator
SpineThera Australia PTY LTD

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary		From baseline through 180 days
Primary	The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).		Baseline to 60 days
Secondary	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
Secondary	Change in Functional Outcomes as Measured by Patient's Global Impression of Change	Very much improved, or much improved from baseline	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary	Change in Functional Outcomes as Measured by the Oswestry Disability Index	0 - 20%: Minimal disability 21% - 40%: Moderate disability 41% - 60%: Severe disability 61% - 80%: Crippling back pain 81% - 100%: Bed-bound or exaggerating their symptoms	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary	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. Each health concept has a range of possible total scores from 0 to 100. A high score defines a more favorable health state. The mean overall total score will be reported.	Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary	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
Secondary	Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary		Baseline through 180 days
Secondary	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