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Recruiting NCT07264270

Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

Phase I Interventional Lumbosacral Radicular Pain Sciatic Radiculopathy Sciatic Leg Pain Sciatica

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-1101, Placebo: Sterile Saline.
Who it may be relevant to
Registry conditions: Lumbosacral Radicular Pain, Sciatic Radiculopathy, Sciatic Leg Pain, Sciatica. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy

Overview

The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline

Interventions

  • Drug C-1101
    C-1101
  • Other Placebo: Sterile Saline
    Placebo

Primary outcome measures

  • Incidence and severity of treatment emergent adverse events (TEAEs) [Time frame: From Day 1 to Week 24]
  • Incidence and severity of adverse events of special interest (AESIs) [Time frame: From Day 1 to Week 24]

Eligibility criteria

Inclusion criteria

  • Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
  • Body mass index < 35 kg/m2.

Exclusion criteria

  • Presence of clinically significant disease or any other painful condition that may interfere with assessments.
  • Any condition that currently requires blood or platelet transfusions.
  • Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.
  • Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors.
  • History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies.
  • History of myocardial infarction within the last 6 months or congestive heart failure.
  • The presence of an active malignancy or tumor.
  • Have undergone a surgical procedure for back pain.
  • Recent use of immunosuppressants, oral steroids, or intravenous steroids.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • Consano Bio Research Site — Broadmeadow
  • Consano Bio Research Site — Wahroonga
  • Consano Bio Research Site — Melbourne

Identifiers

NCT: NCT07264270 · C-1101-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗