Actively Recruiting
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Led by Consano Bio · Updated on 2026-03-17
24
Participants Needed
3
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of painful lumbosacral radiculopathy (sciatica) with pain radiating to or below the knee, not responding adequately to conservative care
- Body mass index less than 35 kg/m2
- Age between 18 and 65 years
- Both males and females are eligible
You will not qualify if you...
- Clinically significant disease or other painful conditions interfering with assessments
- Need for blood or platelet transfusions
- Diagnosis of schizophrenia, bipolar disorder, or major depressive disorder
- Increased risk of bleeding or current use of 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
- Presence of active malignancy or tumor
- Prior surgical procedure for back pain
- Recent use of immunosuppressants, oral steroids, or intravenous steroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Consano Bio Research Site
Broadmeadow, New South Wales, Australia
Actively Recruiting
2
Consano Bio Research Site
Wahroonga, New South Wales, Australia
Actively Recruiting
3
Consano Bio Research Site
Melbourne, Victoria, Australia
Actively Recruiting
Research Team
S
Senior Director, Clinical Development Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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