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

NCT03952377 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: CLIN-0012-STA19-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 10

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.

Conditions

Lumbar Radiculopathy

Keywords

Sciatica; Low Back Pain; Lumbosacral Radiculopathy; Leg Pain

Outcome Measures

Primary Outcomes (1)

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

  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)

  Baseline to 14, 30, 60, 90, 120, 150, and 180 days

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

  Baseline, 14, 30, 60, 90, 120, 150, and 180 days

• Change in Functional Outcomes as Measured by the Oswestry Disability Index

  Baseline, 14, 30, 60, 90, 120, 150, and 180 days

• Change From Baseline in Short Form 36 Questionnaire (SF-36)

  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)

  Baseline to 14, 30, 60, 90, 120, 150, and 180 days

Other Outcomes (1)

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

  From baseline through 180 days

Study Arms (3)

0.9% Sodium Chloride for Injection

PLACEBO COMPARATOR

Drug: Placebo

12.5 mg SX600

EXPERIMENTAL

Low Dose

Drug: SX600

25.0 mg SX600

EXPERIMENTAL

High Dose

Drug: SX600

Interventions

SX600 DRUG

Transforaminal Epidural Injection

12.5 mg SX600; 25.0 mg SX600

Placebo DRUG

Transforaminal Epidural Injection

0.9% Sodium Chloride for Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SpineThera Australia PTY LTD: lead

Study Sites (10)

Research Site 03

Adelaide, Australia

Location

Research Site 12

Adelaide, Australia

Location

Research Site 10

Blacktown, Australia

Location

Research Site 06

Frankston, Australia

Location

Research Site 05

Newcastle, Australia

Location

Research Site 02

Sydney, Australia

Location

Research Site 04

Sydney, Australia

Location

Research Site 09

Sydney, Australia

Location

Research Site 11

Sydney, Australia

Location

Research Site 08

Townsville, Australia

Location

MeSH Terms

Conditions

Radiculopathy; Sciatica; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Sciatic Neuropathy; Mononeuropathies; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

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.

Results Point of Contact

• Title: Jeff Missling, CEO
• Organization: SpineThera

jmissling@spinethera.com

+1(612)-508-4795

Study Officials

• Willem Volschenk

  Genesis Research Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: November 4, 2019
• Primary Completion: February 21, 2022
• Study Completion: June 21, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (10)