Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03952377
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
SpineThera Australia PTY LTD

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.

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Drug: SX600 Drug: Placebo Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group 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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Placebo Comparator: 0.9% Sodium Chloride for Injection Drug: Placebo
Transforaminal Epidural Injection

Experimental: 12.5 mg SX600
Low Dose
Drug: SX600
Transforaminal Epidural Injection

Experimental: 25.0 mg SX600
High Dose
Drug: SX600
Transforaminal Epidural Injection




Primary Outcome Measures :
  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 Outcome Measures :
  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 [ Time Frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days ]
  3. Change in functional outcomes as measured by the Oswestry Disability Index [ Time Frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days ]
  4. Change from baseline in Short Form 36 Questionnaire (SF-36) [ Time Frame: Baseline, 14, 30, 60, 90, 120, 150, and 180 days ]
    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. The total score will be reported and the range of possible total scores is 0 to 100. A high score defines a more favorable health state.

  5. The proportion of subjects who are Responders (defined as having a 30% or greater improvement in mean Worst Daily Leg Pain) [ Time Frame: 14, 30, 60, 90, 120, 150, and 180 days ]
  6. Proportion of subjects who reduce dose of concomitant analgesics from baseline, as reported in patient diary [ Time Frame: 14, 30, 60, 90, 120, 150, and 180 days ]
  7. Proportion of subjects who reduce utilization of supportive health services from baseline, as reported in patient diary [ Time Frame: 14, 30, 60, 90, 120, 150, and 180 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952377


Contacts
Layout table for location contacts
Contact: VP of Research & Development 612.444.1154 emeyering@spinethera.com
Contact: Chief Medical Officer 612.444.1154 cmo@spinethera.com

Sponsors and Collaborators
SpineThera Australia PTY LTD
Investigators
Layout table for investigator information
Principal Investigator: Paul Verrils Metro Pain Group

Layout table for additonal information
Responsible Party: SpineThera Australia PTY LTD
ClinicalTrials.gov Identifier: NCT03952377     History of Changes
Other Study ID Numbers: CLIN-0012-STA19-01
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by SpineThera Australia PTY LTD:
Sciatica
Low Back Pain
Lumbosacral Radiculopathy
Leg Pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases