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TerminatedNCT03952377SALIENTUpdated Jan 10, 2024Results posted

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

A Phase 1/2 interventional study of SX600 and Placebo in Lumbar Radiculopathy, sponsored by SpineThera Australia PTY LTD. Terminated at 10 sites in Australia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by SpineThera Australia PTY LTD · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients
Phase
Phase 1/2
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Lumbar Radiculopathy

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Keywords

  • Sciatica
  • Low Back Pain
  • Lumbosacral Radiculopathy
  • Leg Pain
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 56 is close to the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

This is the only study on the registry with SpineThera Australia PTY LTD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Placebo comparator
    0.9% Sodium Chloride for Injection

    Drug: Placebo

  • Experimental
    12.5 mg SX600

    Low Dose

    Drug: SX600

  • Experimental
    25.0 mg SX600

    High Dose

    Drug: SX600

Interventions

  • DrugSX600

    Transforaminal Epidural Injection

  • DrugPlacebo

    Transforaminal Epidural Injection

06

What researchers measure

Primary outcomes

  1. The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).

    Time frame: Baseline to 60 days

Secondary outcomes

  1. 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

  2. Change in Functional Outcomes as Measured by Patient's Global Impression of Change

    Very much improved, or much improved from baseline

    Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days

  3. 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

    Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days

  4. 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.

    Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days

  5. 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

  6. Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary

    Time frame: Baseline through 180 days

  7. 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: Day 14 through 180 days

Other outcomes

  1. Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary

    Time frame: From baseline through 180 days

07

Results

Posted Jan 10, 2024
Limitations and caveats
Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients.

Participant flow

Participant flow — Overall Study
Milestone0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Started182117
Completed161916
Not completed221

Outcome measures

PrimaryThe Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Time frame:
Baseline to 60 days
Reported as:
Count of participants · Participants
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Participants0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).21010
SecondaryThe 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
Reported as:
Number · percentage of participants
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
percentage of participants0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Baseline to 14 days22.242.143.8
Baseline to 30 days17.638.966.7
Baseline to 90 days43.852.666.7
Baseline to 120 days46.746.764.3
Baseline to 150 days41.746.771.4
Baseline to 180 days38.546.769.2
SecondaryChange in Functional Outcomes as Measured by Patient's Global Impression of Change

Very much improved, or much improved from baseline

Time frame:
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Reported as:
Number · percentage of participants
Change in Functional Outcomes as Measured by Patient's Global Impression of Change
percentage of participants0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Baseline to 14 days16.736.856.3
Baseline to 30 days23.54553.3
Baseline to 60 days23.24560
Baseline to 90 days5038.960
Baseline to 120 days46.246.757.1
Baseline to 150 days58.346.757.1
Baseline to 180 days66.650.171.5
SecondaryChange 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

Time frame:
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Reported as:
Mean · score on scale of 0% to 100%
Change in Functional Outcomes as Measured by the Oswestry Disability Index
score on scale of 0% to 100%0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Baseline27.99 ± 9.52535.21 ± 12.84432.83 ± 16.113
14 days22.97 ± 12.73021.04 ± 14.46319.72 ± 19.506
30 days19.22 ± 10.34121.12 ± 16.46416.89 ± 19.427
60 days17.64 ± 11.30616.50 ± 13.83915.31 ± 19.237
90 days17.06 ± 12.84114.67 ± 10.84716.95 ± 22.502
120 days12.8 ± 8.19316.53 ± 12.79419.59 ± 24.574
150 days11.89 ± 6.57814.13 ± 11.42612.74 ± 11.994
180 days12.23 ± 7.20815 ± 13.7799.74 ± 8.781
SecondaryChange 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.

Time frame:
Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Reported as:
Mean · score on a scale
Change From Baseline in Short Form 36 Questionnaire (SF-36)
score on a scale0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Baseline61.03 (0 to 100)51.04 (0 to 100)48.40 (0 to 100)
14 days60.85 (0 to 100)63.73 (0 to 100)61.89 (0 to 100)
30 days64.02 (0 to 100)63.28 (0 to 100)67.93 (0 to 100)
60 days66.17 (0 to 100)73.26 (0 to 100)69.29 (0 to 100)
90 days69.07 (0 to 100)73.22 (0 to 100)68.8 (0 to 100)
120 days77.32 (0 to 100)69.49 (0 to 100)68 (0 to 100)
150 days73.92 (0 to 100)76 (0 to 100)72.44 (0 to 100)
180 days77.83 (0 to 100)72.57 (0 to 100)77.29 (0 to 100)
SecondaryThe 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
Reported as:
Number · percentage of participants
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
percentage of participants0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
14 days27.852.668.8
30 days29.461.180
60 days5073.778.6
90 days506066.7
120 days53.35071.4
150 days46.262.571.4
180 days46.75076.9
SecondaryProportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Time frame:
Baseline through 180 days
Reported as:
Count of participants · Participants
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Participants0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary733
SecondaryTime 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:
Day 14 through 180 days
Reported as:
Mean · days
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)
days0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
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)40.8 ± 7.5440.8 ± 6.19103.3 ± 2.24
Other pre-specifiedProportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary
Time frame:
From baseline through 180 days

No measurements were reported for this outcome.

Adverse events

Collected over 180 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
0.9% Sodium Chloride for Injection0/18 (0%)3/18 (16.7%)15/18 (83.3%)
12.5 mg SX6000/21 (0%)0/21 (0%)16/21 (76.2%)
25.0 mg SX6000/16 (0%)1/16 (6.3%)14/16 (87.5%)
Most frequent serious events
Most frequent serious events
Event0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Renal ColicRenal and urinary disorders0/180/211/16
Small Intestinal ObstructionGastrointestinal disorders1/180/210/16
Back PainMusculoskeletal and connective tissue disorders1/180/210/16
RadiculopathyNervous system disorders1/180/210/16
Most frequent other events
Showing 10 of 65
Most frequent other events
Event0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600
Back painMusculoskeletal and connective tissue disorders5/182/212/16
PainGeneral disorders5/180/211/16
Alanine aminotransferase increasedInvestigations0/184/212/16
Blood creatine phosphokinase increasedInvestigations2/181/213/16
HypoesthesiaNervous system disorders3/182/210/16
Blood cholesterol increasedInvestigations2/182/212/16
Blood lactate dehydrogenase increasedInvestigations2/181/212/16
Aspartate aminotransferase increasedInvestigations0/180/212/16
Urinary tract infectionInfections and infestations0/181/212/16
Low density lipoprotein increasedInvestigations2/182/211/16

Baseline characteristics

ITT Population

Age, Continuous
Age, Continuous(years)0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600Total
Mean45.1 ± 6.7747.7 ± 7.2552.0 ± 4.8648.1 ± 6.93
Sex: Female, Male
Sex: Female, Male(Participants)0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600Total
Female75719
Male11161037
Race (NIH/OMB)
Race (NIH/OMB)(Participants)0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600Total
American Indian or Alaska Native0000
Asian2305
Native Hawaiian or Other Pacific Islander1001
Black or African American0000
White13171444
More than one race0000
Unknown or Not Reported2136
Region of Enrollment
Region of Enrollment(participants)0.9% Sodium Chloride for Injection12.5 mg SX60025.0 mg SX600Total
Australia18211756
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Study locations

10 sites
  • 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, Australia
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References and documents

Study documents

  • Study protocol · Jun 17, 2020
  • Statistical analysis plan · Jul 13, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03952377
Lead sponsor
SpineThera Australia PTY LTD
Responsible party
Sponsor
First posted
May 16, 2019
Start date
Nov 4, 2019
Primary completion
Feb 21, 2022
Completion
Jun 21, 2022
Results posted
Jan 10, 2024
Last update
Jan 10, 2024

Study contacts

Willem Volschenk
principal investigator · Genesis Research Services

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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