Lumbar RadiculopathyPhase 1/2SALIENTNCT03952377
Safety and Efficacy of SX600 Administered by Lumbosacral Transforaminal Epidural Injection for Radicular Pain
A Phase 1/2 study testing SX600 in people with Lumbar Radiculopathy, run by SpineThera Australia PTY LTD at 10 sites in Australia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- SX600
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 10 sitesAustralia
- Study dates
- 4 Nov 2019to 21 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
Research Site 03
Adelaide
Research Site 12
Adelaide
Research Site 10
Blacktown
Research Site 06
Frankston
Research Site 05
Newcastle
Research Site 02
Sydney
Research Site 04
Sydney
Research Site 09
Sydney
Research Site 11
Sydney
Research Site 08
Townsville
About this study
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
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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- SX600, Placebo
- Keywords
- Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain
- Medical subject headings
- Radiculopathy, Sciatica, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SX600Drug
Transforaminal Epidural Injection
PlaceboDrug
Transforaminal Epidural Injection
| Study group | Role | What they receive |
|---|---|---|
| 0.9% Sodium Chloride for Injection | Placebo comparator | Not described Receives: Drug: Placebo |
| 12.5 mg SX600 | Experimental | Low Dose Receives: Drug: SX600 |
| 25.0 mg SX600 | Experimental | High Dose Receives: Drug: SX600 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Measured: Baseline to 60 days
Secondary outcomes (7)
The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain)
Measured: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Change in Functional Outcomes as Measured by Patient's Global Impression of Change
Very much improved, or much improved from baseline
Measured: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
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
Measured: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
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.
Measured: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain)
Measured: Baseline to 14, 30, 60, 90, 120, 150, and 180 days
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Measured: Baseline through 180 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)
Measured: Day 14 through 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start4 Nov 2019
- Primary completion21 Feb 2022
- Study completion21 Jun 2022
Why it stopped: Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- SpineThera Australia PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Willem Volschenk, Principal investigator, Genesis Research Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952377
- Sponsor's protocol ID
- CLIN-0012-STA19-01
- Acronym
- SALIENT
- Status last verified
- Dec 2023
- First submitted
- 13 May 2019
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03952377
- Acronym / sponsor ID
- SALIENT / CLIN-0012-STA19-01
- Conditions
- Lumbar Radiculopathy
- Keywords
- Sciatica, Low Back Pain, Lumbosacral Radiculopathy, Leg Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the impact of COVID-19 and associated enrollment difficulties, the study was terminated with a total sample size of 56 randomized patients
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SpineThera Australia PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Posted 10 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.9% Sodium Chloride for Injection | Placebo comparator | Drug: Placebo |
| 12.5 mg SX600 | Experimental | Drug: SX600Low Dose |
| 25.0 mg SX600 | Experimental | Drug: SX600High Dose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SX600Transforaminal Epidural Injection | Drug | 12.5 mg SX600, 25.0 mg SX600 |
| PlaceboTransforaminal Epidural Injection | Drug | 0.9% Sodium Chloride for Injection |
Primary outcome
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders).
Time frame: Baseline to 60 days
7 secondary outcomes
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
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
Change in Functional Outcomes as Measured by the Oswestry Disability Index
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
Change From Baseline in Short Form 36 Questionnaire (SF-36)
Time frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days
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
Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary
Time frame: Baseline through 180 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)
Time frame: Day 14 through 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem Volschenk principal investigator
Genesis Research Services
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SX600 in people with Lumbar Radiculopathy, run by SpineThera Australia PTY LTD at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). (time frame: Baseline to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.