Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001235190
Ethics application status
Approved
Date submitted
29/07/2019
Date registered
6/09/2019
Date last updated
22/08/2022
Date data sharing statement initially provided
6/09/2019
Date results information initially provided
2/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain (SALIENT)
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] 298874 0
NCT03952377
Secondary ID [2] 298875 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 313834 0
low back pain 313835 0
sciatica 313836 0
leg pain 313837 0
Lumbosacral Radiculopathy 313838 0
radiculopathy 315567 0
Peripheral nervous system disease 315568 0
Neuromuscular disease 315569 0
Nervous system disease 315570 0
Condition category
Condition code
Anaesthesiology 312235 312235 0 0
Pain management
Neurological 312388 312388 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three groups:
Treatment: Drugs - SX600 low dose and high dose
Treatment: Drugs - Placebo

Single administration, once only

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] 315138 0
Treatment: Drugs
Comparator / control treatment
Placebo Comparator: 0.9% Sodium Chloride for Injection
Control group
Placebo

Outcomes
Primary outcome [1] 320883 0
The proportion of subjects with a 50% or greater improvement in mean Worst Daily Leg Pain (Responsders) assessed by a standard Numeric Rating Scale (NRS-11) for patient self-reporting of pain.
Timepoint [1] 320883 0
Baseline to 60 days
Secondary outcome [1] 373246 0
The proportion of subjects who are Responders (defined as having a 50% or greater improvement in mean Worst Daily Leg Pain) assessed by a standard Numeric Rating Scale (NRS-11) for patient self-reporting of pain.
Timepoint [1] 373246 0
Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [2] 373247 0
Change in functional outcomes as measured by Patient's Global Impression of Change
Timepoint [2] 373247 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [3] 373248 0
Change in functional outcomes as measured by the Oswestry Disability Index
Timepoint [3] 373248 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [4] 373249 0
Change in baseline in Short Form 36 Questionnaire (SF-36).
Timepoint [4] 373249 0
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [5] 373250 0
The proportion of subjects who are Responders (defined as having a 30% or greater improvement in mean Worst Daily Leg Pain) assessed by a standard Numeric Rating Scale (NRS-11) for patient self-reporting of pain.
Timepoint [5] 373250 0
14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [6] 373251 0
Proportion of subjects who reduce dose of concomitant analgesics from baseline, as reported in patient diary
Timepoint [6] 373251 0
14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [7] 373252 0
Proportion of subjects who reduce utilization of supportive health services from baseline, as reported in patient diary
Timepoint [7] 373252 0
14, 30, 60, 90, 120, 150, and 180 days
Secondary outcome [8] 373720 0
Adverse events will be collected using a daily patient diary and during study visits to the study site. Adverse events will be explained to you by the study doctor and may include: allergic reactions, changes in heart rate, heart rhythm or the pumping efficiency of your heart, swelling, blood clots, acne and skin changes, hormone changes and musculoskeletal changes.
Timepoint [8] 373720 0
From the day treatment is administered, to the conclusion of the study - approximately 180 days.
Secondary outcome [9] 373721 0
Serious adverse events considered product or procedure-related. Adverse events will be collected using a daily patient diary and during study visits to the study site. Adverse events will be explained to you by the study doctor and may include: allergic reactions, changes in heart rate, heart rhythm or the pumping efficiency of your heart, swelling, blood clots, acne and skin changes, hormone changes and musculoskeletal changes.
Timepoint [9] 373721 0
From the day treatment is administered, to the conclusion of the study - approximately 180 days.
Secondary outcome [10] 377883 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 [10] 377883 0
30, 60, 90, 120, 150 and 180 days.

Eligibility
Key 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 more than 5.0 and less than 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
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, spinal
stenosis, or spondylolisthesis

- Has Diabetes Mellitus (Type 1 or Type 2)

- 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 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2019
Actual
19/11/2019
Date of last participant enrolment
Anticipated
31/12/2022
Actual
7/12/2021
Date of last data collection
Anticipated
30/06/2023
Actual
21/06/2022
Sample size
Target
120
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment postcode(s) [1] 35776 0
2050 - Camperdown
Recruitment postcode(s) [2] 35777 0
2065 - St Leonards
Recruitment postcode(s) [3] 35771 0
2076 - Wahroonga
Recruitment postcode(s) [4] 35774 0
2148 - Blacktown
Recruitment postcode(s) [5] 28805 0
2220 - Hurstville
Recruitment postcode(s) [6] 28804 0
2292 - Broadmeadow
Recruitment postcode(s) [7] 35780 0
2505 - Port Kembla
Recruitment postcode(s) [8] 35772 0
3199 - Frankston
Recruitment postcode(s) [9] 35773 0
4814 - Douglas
Recruitment postcode(s) [10] 35775 0
5000 - Adelaide
Recruitment postcode(s) [11] 35778 0
5034 - Wayville
Recruitment postcode(s) [12] 35779 0
6011 - Cottesloe

Funding & Sponsors
Funding source category [1] 303419 0
Commercial sector/Industry
Name [1] 303419 0
SpineThera Australia Pty ltd
Country [1] 303419 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
SpineThera Australia PTY LTD
Address
C/- Prime Accounting and Business Advisory Pty Ltd
Level 19, 40 City Road, Southbank, VIC, 3006
Country
Australia
Secondary sponsor category [1] 303469 0
None
Name [1] 303469 0
None
Address [1] 303469 0
None
Country [1] 303469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303949 0
Bellberry Ltd
Ethics committee address [1] 303949 0
123 Glen Osmond Road Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 303949 0
Australia
Date submitted for ethics approval [1] 303949 0
15/05/2019
Approval date [1] 303949 0
23/08/2019
Ethics approval number [1] 303949 0
2019-04-371
Ethics committee name [2] 303950 0
CALHN HREC
Ethics committee address [2] 303950 0
RAH Clinical Trial Centre, Wayfinder 3D460.02, Level 3, Royal Adelaide Hospital, Port Road, ADELAIDE SA 5000
Ethics committee country [2] 303950 0
Australia
Date submitted for ethics approval [2] 303950 0
27/06/2019
Approval date [2] 303950 0
Ethics approval number [2] 303950 0

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
www.salientstudy.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95350 0
Dr Willem Volschenk
Address 95350 0
Genesis Research Services. 220 Denison Street, Broadmedow, 2292, NSW
Country 95350 0
Australia
Phone 95350 0
+61249851860
Fax 95350 0
Email 95350 0
Willem@genesisresearchservices.com
Contact person for public queries
Name 95351 0
Heather Macdonald
Address 95351 0
Genesis Research Services 220 Denison Street, Broadmedow, 2292, NSW
Country 95351 0
Australia
Phone 95351 0
+61249851800
Fax 95351 0
Email 95351 0
heather@genesisresearchservices.com
Contact person for scientific queries
Name 95352 0
Anita van der Meer
Address 95352 0
SpineThera Australia Pty Ltd
C/- Prime Accounting and Business Advisory Pty Ltd
Level 19, 40 City Road, Southbank, VIC, 3006
Country 95352 0
Australia
Phone 95352 0
+61 1800577457
Fax 95352 0
Email 95352 0
anita.l.vandermeer@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD at this time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.