Lumbar Radiculopathy Clinical Trial
— SALIENTOfficial 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
Verified date | December 2023 |
Source | SpineThera Australia PTY LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 56 |
Est. completion date | June 21, 2022 |
Est. primary completion date | February 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | 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 |
Lead Sponsor | Collaborator |
---|---|
SpineThera Australia PTY LTD |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of Subjects Who Reduce Utilization of Supportive Health Services From Baseline, as Reported in Patient Diary | From baseline through 180 days | ||
Primary | The Proportion of Subjects With a 50% or Greater Improvement in Mean Worst Daily Leg Pain (Responders). | Baseline to 60 days | ||
Secondary | The Proportion of Subjects Who Are Responders (Defined as Having a 50% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14, 30, 60, 90, 120, 150, and 180 days | ||
Secondary | Change in Functional Outcomes as Measured by Patient's Global Impression of Change | Very much improved, or much improved from baseline | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | |
Secondary | 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 | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | |
Secondary | 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. | Baseline, 14, 30, 60, 90, 120, 150, and 180 days | |
Secondary | The Proportion of Subjects Who Are Responders (Defined as Having a 30% or Greater Improvement in Mean Worst Daily Leg Pain) | Baseline to 14, 30, 60, 90, 120, 150, and 180 days | ||
Secondary | Proportion of Subjects Who Required Rescue Medication, as Reported in Patient Diary | Baseline through 180 days | ||
Secondary | 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) | Day 14 through 180 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05047679 -
The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy
|
N/A | |
Withdrawn |
NCT03543033 -
Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes
|
N/A | |
Recruiting |
NCT06076408 -
Effects of SNAGS With and Without Pilates in Lumbar Disc Bulge Patients
|
N/A | |
Completed |
NCT03133845 -
Shaping Anesthetic Techniques to Reduce Post-operative Delirium
|
N/A | |
Completed |
NCT06087107 -
Comparative Effects Of High Intensity Spinal Decompression Exercises And Eldoa In Patients Of Lumbar Radiculopathy
|
N/A | |
Completed |
NCT04852900 -
Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy
|
N/A | |
Terminated |
NCT05022251 -
Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy
|
||
Recruiting |
NCT04212949 -
The Effect of Transcranial Magnetic Stimulation Therapy in Patients With Lumbar Radiculopathy
|
N/A | |
Recruiting |
NCT06339931 -
Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.
|
N/A | |
Recruiting |
NCT04540068 -
Prediction of TEI Success in Sciatica
|
||
Recruiting |
NCT05922228 -
Effects of Neural Flossing and PNF on Lumbar Radiculopathy
|
N/A | |
Recruiting |
NCT05953727 -
Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients
|
N/A | |
Completed |
NCT05449288 -
Urdu Version Of Modified Oswestry Low Back Pain Scale; A Reliability And Validity Study
|
||
Completed |
NCT05874427 -
Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
|
N/A | |
Terminated |
NCT01443819 -
Lumbar Transforaminal Epidural Corticosteroid Injection(s) Versus Defined Physical Therapy
|
Phase 3 | |
Recruiting |
NCT05535010 -
The Effect of the Presence of Active Trigger Points in the Muscles Innervated by the Affected Nerve Roots on the Treatment Results of Transforaminal Epidural Steroid Injection in Patients With Lumbar Radiculopathy.
|
N/A | |
Recruiting |
NCT06154005 -
OsteoAdapt SP Advanced Bone Graft Feasibility Study - Transforaminal Interbody Lumbar Fusion
|
Phase 1/Phase 2 | |
Completed |
NCT04674917 -
Effects of Decompression in Patient With Acute vs Chronic Lumbar Radiculopathy
|
N/A | |
Not yet recruiting |
NCT06296303 -
Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients
|
N/A | |
Completed |
NCT04887285 -
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
|
N/A |