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

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SX600
Placebo
Sponsored by
SpineThera Australia PTY LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site 03
  • Research Site 12
  • Research Site 10
  • Research Site 06
  • Research Site 05
  • Research Site 02
  • Research Site 04
  • Research Site 09
  • Research Site 11
  • Research Site 08

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

0.9% Sodium Chloride for Injection

12.5 mg SX600

25.0 mg SX600

Arm Description

Low Dose

High Dose

Outcomes

Primary Outcome Measures

The proportion of subjects with a 50% or greater improvement in mean Worst Daily Leg Pain (Responders).

Secondary Outcome Measures

The proportion of subjects who are Responders (defined as having a 50% or greater improvement in mean Worst Daily Leg Pain)
Change in functional outcomes as measured by Patient's Global Impression of Change
Change in functional outcomes as measured by the Oswestry Disability Index
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.
The proportion of subjects who are Responders (defined as having a 30% or greater improvement in mean Worst Daily Leg Pain)
Proportion of subjects who reduce dose of concomitant analgesics from baseline, as reported in patient diary
Proportion of subjects who reduce utilization of supportive health services from baseline, as reported in patient diary
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)

Full Information

First Posted
May 13, 2019
Last Updated
August 1, 2022
Sponsor
SpineThera Australia PTY LTD
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1. Study Identification

Unique Protocol Identification Number
NCT03952377
Brief Title
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
February 21, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SpineThera Australia PTY LTD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.9% Sodium Chloride for Injection
Arm Type
Placebo Comparator
Arm Title
12.5 mg SX600
Arm Type
Experimental
Arm Description
Low Dose
Arm Title
25.0 mg SX600
Arm Type
Experimental
Arm Description
High Dose
Intervention Type
Drug
Intervention Name(s)
SX600
Intervention Description
Transforaminal Epidural Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Transforaminal Epidural Injection
Primary Outcome Measure Information:
Title
The proportion of subjects with a 50% or greater improvement in mean Worst Daily Leg Pain (Responders).
Time Frame
Baseline to 60 days
Secondary Outcome Measure Information:
Title
The proportion of subjects who are Responders (defined as having a 50% or greater improvement in mean Worst Daily Leg Pain)
Time Frame
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Title
Change in functional outcomes as measured by Patient's Global Impression of Change
Time Frame
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Title
Change in functional outcomes as measured by the Oswestry Disability Index
Time Frame
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Title
Change from baseline in Short Form 36 Questionnaire (SF-36)
Description
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.
Time Frame
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Title
The proportion of subjects who are Responders (defined as having a 30% or greater improvement in mean Worst Daily Leg Pain)
Time Frame
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Title
Proportion of subjects who reduce dose of concomitant analgesics from baseline, as reported in patient diary
Time Frame
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Title
Proportion of subjects who reduce utilization of supportive health services from baseline, as reported in patient diary
Time Frame
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Title
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)
Time Frame
30, 60, 90, 120, 150, and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem Volschenk
Organizational Affiliation
Genesis Research Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site 03
City
Adelaide
Country
Australia
Facility Name
Research Site 12
City
Adelaide
Country
Australia
Facility Name
Research Site 10
City
Blacktown
Country
Australia
Facility Name
Research Site 06
City
Frankston
Country
Australia
Facility Name
Research Site 05
City
Newcastle
Country
Australia
Facility Name
Research Site 02
City
Sydney
Country
Australia
Facility Name
Research Site 04
City
Sydney
Country
Australia
Facility Name
Research Site 09
City
Sydney
Country
Australia
Facility Name
Research Site 11
City
Sydney
Country
Australia
Facility Name
Research Site 08
City
Townsville
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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