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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03952377




Registration number
NCT03952377
Ethics application status
Date submitted
13/05/2019
Date registered
16/05/2019
Date last updated
10/01/2024

Titles & IDs
Public title
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
Scientific 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
Secondary ID [1] 0 0
CLIN-0012-STA19-01
Universal Trial Number (UTN)
Trial acronym
SALIENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar Radiculopathy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SX600
Treatment: Drugs - Placebo

Placebo comparator: 0.9% Sodium Chloride for Injection -

Experimental: 12.5 mg SX600 - Low Dose

Experimental: 25.0 mg SX600 - High Dose


Treatment: Drugs: SX600
Transforaminal Epidural Injection

Treatment: Drugs: Placebo
Transforaminal Epidural Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Timepoint [1] 0 0
Baseline to 60 days
Secondary outcome [1] 0 0
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
Timepoint [1] 0 0
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [2] 0 0
Change in Functional Outcomes as Measured by Patient's Global Impression of Change
Timepoint [2] 0 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [3] 0 0
Change in Functional Outcomes as Measured by the Oswestry Disability Index
Timepoint [3] 0 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [4] 0 0
Change From Baseline in Short Form 36 Questionnaire (SF-36)
Timepoint [4] 0 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [5] 0 0
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
Timepoint [5] 0 0
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [6] 0 0
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Timepoint [6] 0 0
Baseline through 180 days
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Day 14 through 180 days

Eligibility
Key inclusion criteria
Main

* 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/06/2022
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site 03 - Adelaide
Recruitment hospital [2] 0 0
Research Site 12 - Adelaide
Recruitment hospital [3] 0 0
Research Site 10 - Blacktown
Recruitment hospital [4] 0 0
Research Site 06 - Frankston
Recruitment hospital [5] 0 0
Research Site 05 - Newcastle
Recruitment hospital [6] 0 0
Research Site 02 - Sydney
Recruitment hospital [7] 0 0
Research Site 04 - Sydney
Recruitment hospital [8] 0 0
Research Site 09 - Sydney
Recruitment hospital [9] 0 0
Research Site 11 - Sydney
Recruitment hospital [10] 0 0
Research Site 08 - Townsville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Blacktown
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Townsville

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SpineThera Australia PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03952377
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Willem Volschenk
Address 0 0
Genesis Research Services
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03952377